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Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

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ClinicalTrials.gov Identifier: NCT00677833
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malaria, Falciparum
Interventions Drug: Azithromycin plus Chloroquine
Drug: Artemether-lumefantrine
Enrollment 361
Recruitment Details Participants were recruited in 2 age-based Cohorts. Cohort 1=participants between 5-12 years of age, assumed to have some degree of immunity and at less risk for untoward outcome. After demonstration of successful treatment, safety and tolerability in Cohort 1, participants between >=6 months of age to <=59 months of age were enrolled in Cohort 2.
Pre-assignment Details Participants were enrolled in 2 cohorts based on different age criteria. All participants in Cohort 1 met the age criteria where as 3 participants enrolled in Cohort 2 were slightly older than 5 years (by less than 2 months).
Arm/Group Title Cohort 1: Azithromycin + Chloroquine Cohort 1: Artemether + Lumefantrine Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (>=) 5 years of age and less than or equal to (<=) 12 years of age. Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age. Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age. Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Period Title: Overall Study
Started 55 51 124 131
Completed 51 51 122 128
Not Completed 4 0 2 3
Reason Not Completed
Withdrawal by Subject             4             0             1             3
Lost to Follow-up             0             0             1             0
Arm/Group Title Cohort 1: Azithromycin + Chloroquine Cohort 1: Artemether + Lumefantrine Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine Total
Hide Arm/Group Description Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between >=5 years of age and <=12 years of age.

Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2.

Cohort 1 included participants between >=5 years of age and <=12 years of age.

Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age. Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. Total of all reporting groups
Overall Number of Baseline Participants 55 51 124 131 361
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 124 participants 131 participants 361 participants
6 months - less than 5 years 0 0 123 129 252
5 years - 12 years 55 51 1 2 109
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 124 participants 131 participants 361 participants
Female
28
  50.9%
21
  41.2%
50
  40.3%
65
  49.6%
164
  45.4%
Male
27
  49.1%
30
  58.8%
74
  59.7%
66
  50.4%
197
  54.6%
1.Primary Outcome
Title Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population
Hide Description ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)– see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter [mcL];fever/history of fever >=38 degree Celsius[C] [rectal],37.2 degree C [axillary] or >=37.5 degree C [oral] within last 24 hours).Participants in Ivory Coast center excluded from analysis.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 120 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
89.27
(82.77 to 95.77)
98.37
(95.59 to 100.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was >= -10% points.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -9.10
Confidence Interval (2-Sided) 95%
-16.02 to -2.18
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population
Hide Description ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 114 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
93.08
(87.32 to 98.84)
99.16
(96.97 to 100.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was >= -10% points.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -6.08
Confidence Interval (2-Sided) 95%
-12.10 to -0.05
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With PCR-corrected ACPR in the mITT Population
Hide Description ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Days 7, 14, 21, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 120 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7
94.17
(89.55 to 98.78)
99.21
(97.25 to 100.00)
Day 14
92.47
(87.30 to 97.64)
99.21
(97.24 to 100.00)
Day 21
91.59
(86.04 to 97.14)
98.37
(95.65 to 100.00)
Day 35
89.27
(82.68 to 95.86)
96.19
(91.85 to 100.00)
Day 42
87.55
(80.08 to 95.03)
96.19
(91.79 to 100.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -5.04
Confidence Interval (2-Sided) 95%
-9.93 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -6.74
Confidence Interval (2-Sided) 95%
-12.15 to -1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -6.78
Confidence Interval (2-Sided) 95%
-12.82 to -0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -6.92
Confidence Interval (2-Sided) 95%
-14.59 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -8.63
Confidence Interval (2-Sided) 95%
-17.08 to -0.18
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With PCR-corrected ACPR in PP Population
Hide Description ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Days 7, 14, 21, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 114 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7
98.25
(95.39 to 100.00)
100.00 [1] 
(NA to NA)
Day 14
96.46
(92.59 to 100.00)
100.00 [1] 
(NA to NA)
Day 21
95.53
(91.10 to 99.96)
99.16
(97.03 to 100.00)
Day 35
93.08
(87.22 to 98.95)
96.96
(92.90 to 100.00)
Day 42
91.29
(84.31 to 98.28)
96.96
(92.84 to 100.00)
[1]
Confidence interval was not calculable as standard error for 100% rate could not be estimated from Kaplan-Meier method.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier, curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -3.63
Confidence Interval (2-Sided) 95%
-8.40 to 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier, curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -3.87
Confidence Interval (2-Sided) 95%
-10.79 to 3.04
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier, curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -5.66
Confidence Interval (2-Sided) 95%
-13.55 to 2.22
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With PCR-uncorrected ACPR in the mITT Population
Hide Description ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.
Time Frame Days 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 120 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7
94.17
(89.55 to 98.78)
99.21
(97.25 to 100.00)
Day 14
89.08
(83.05 to 95.11)
96.79
(93.28 to 100.00)
Day 21
67.87
(59.02 to 76.72)
82.96
(75.91 to 90.01)
Day 28
51.55
(42.07 to 61.02)
73.31
(65.10 to 81.52)
Day 35
44.67
(35.24 to 54.11)
62.91
(54.00 to 71.82)
Day 42
37.80
(28.58 to 47.02)
56.29
(47.12 to 65.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -5.04
Confidence Interval (2-Sided) 95%
-9.93 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -7.71
Confidence Interval (2-Sided) 95%
-14.54 to -0.88
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -15.09
Confidence Interval (2-Sided) 95%
-26.24 to -3.94
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -21.76
Confidence Interval (2-Sided) 95%
-34.14 to -9.39
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -18.24
Confidence Interval (2-Sided) 95%
-31.05 to -5.43
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR Percent difference
Estimated Value -18.49
Confidence Interval (2-Sided) 95%
-31.33 to -5.65
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With PCR-uncorrected ACPR in PP Population
Hide Description ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.
Time Frame Days 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 114 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7
98.25
(95.39 to 100.00)
100.00 [1] 
(NA to NA)
Day 14
92.89
(87.69 to 98.08)
97.56
(94.42 to 100.00)
Day 21
70.56
(61.67 to 79.45)
83.62
(76.65 to 90.60)
Day 28
54.28
(44.57 to 63.98)
73.90
(65.71 to 82.08)
Day 35
47.04
(37.31 to 56.77)
63.41
(54.49 to 72.34)
Day 42
39.80
(30.24 to 49.36)
56.74
(47.54 to 65.94)
[1]
Confidence interval not calculable when rate is 100%.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -4.67
Confidence Interval (2-Sided) 95%
-10.60 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -13.07
Confidence Interval (2-Sided) 95%
-24.21 to -1.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -19.62
Confidence Interval (2-Sided) 95%
-32.16 to -7.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR percent difference
Estimated Value -16.38
Confidence Interval (2-Sided) 95%
-29.42 to -3.33
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)- (AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier curves
Comments [Not Specified]
Method of Estimation Estimation Parameter ACPR Percent difference
Estimated Value -16.94
Confidence Interval (2-Sided) 95%
-30.04 to -3.83
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)
Hide Description

ETF defined as participants who met the following criteria:

  1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia
  2. Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.
  3. Parasitemia (P. falciparum) on Day 3 with fever or
  4. Last available P. falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).

PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Time Frame Day 0 up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, participants in Ivory Coast center were excluded from mITT population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 120 126
Measure Type: Number
Unit of Measure: Percentage of participants
5.83 0.79
8.Secondary Outcome
Title Percentage of Participants With ETF in PP Population (PCR-corrected)
Hide Description

ETF defined as participants who met the following criteria:

  1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia
  2. Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.
  3. Parasitemia (P.falciparum) on Day 3 with fever or
  4. Last available P.falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).

PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Time Frame Day 0 up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
PP population, participants in Ivory Coast center were excluded from the PP population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 114 124
Measure Type: Number
Unit of Measure: Percentage of participants
1.75 0
9.Secondary Outcome
Title Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)
Hide Description

LCF included participants who met any of the following criteria:

  1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)
  2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Days 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, participants in Ivory Coast center were excluded from mITT population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 120 126
Measure Type: Number
Unit of Measure: Percentage of participants
Day 7 0 0
Day 14 0 0
Day 21 0 0
Day 28 0 0
Day 35 0 0
Day 42 0 0
10.Secondary Outcome
Title Percentage of Participants With LCF in PP Population (PCR-corrected)
Hide Description

LCF included participants who met any of the following criteria:

  1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)
  2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Days 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
PP population, participants in Ivory Coast center were excluded from the PP population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 114 124
Measure Type: Number
Unit of Measure: Percentage of participants
Day 7 0 0
Day 14 0 0
Day 21 0 0
Day 28 0 0
Day 35 0 0
Day 42 0 0
11.Secondary Outcome
Title Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)
Hide Description LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Days 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, participants in Ivory Coast center were excluded from mITT population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 120 126
Measure Type: Number
Unit of Measure: Percentage of participants
Day 7 0 0
Day 14 1.67 0
Day 21 2.50 0.79
Day 28 4.17 0.79
Day 35 4.17 2.38
Day 42 5.00 2.38
12.Secondary Outcome
Title Percentage of Participants With LPF in PP Population (PCR-corrected)
Hide Description LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Days 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
PP population, participants in Ivory Coast center were excluded from the PP population.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 114 124
Measure Type: Number
Unit of Measure: Percentage of participants
Day 7 0 0
Day 14 1.75 0
Day 21 2.63 0.81
Day 28 4.39 0.81
Day 35 4.39 2.42
Day 42 5.26 2.42
13.Secondary Outcome
Title Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)
Hide Description Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Day 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 120 128
Measure Type: Number
Unit of Measure: Percentage of participants
Day 7 (n=120, 128) 93.33 99.22
Day 14 (n=120, 127) 91.67 99.21
Day 21 (n=120, 128) 90.83 98.44
Day 28 (n=120, 127) 89.17 98.43
Day 35 (n=120, 128) 89.17 96.88
Day 42 (n=120, 127) 88.33 96.85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -5.89
Confidence Interval (2-Sided) 95%
-11.02 to -0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -7.55
Confidence Interval (2-Sided) 95%
-13.14 to -1.95
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -7.60
Confidence Interval (2-Sided) 95%
-13.61 to -1.60
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -9.26
Confidence Interval (2-Sided) 95%
-15.64 to -2.87
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -7.71
Confidence Interval (2-Sided) 95%
-14.45 to -0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -8.52
Confidence Interval (2-Sided) 95%
-15.43 to -1.60
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Gametocytologic Response
Hide Description Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.
Time Frame Days 7, 14, 21, 28, 35, 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. "N"= participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 122 130
Measure Type: Number
Unit of Measure: Percentage of participants
Day 7 (n=122, 129) 81.97 91.47
Day 14 (n=122, 130) 81.15 91.54
Day 21 (n=122, 130) 80.33 93.08
Day 28 (n=122, 130) 81.97 93.08
Day 35 (n=122, 130) 81.97 92.31
Day 42 (n=122, 130) 80.33 91.54
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -9.51
Confidence Interval (2-Sided) 95%
-18.27 to -0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -10.39
Confidence Interval (2-Sided) 95%
-19.23 to -1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -12.75
Confidence Interval (2-Sided) 95%
-21.45 to -4.04
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -11.11
Confidence Interval (2-Sided) 95%
-19.62 to -2.60
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -10.34
Confidence Interval (2-Sided) 95%
-18.97 to -1.71
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Large sample approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -11.21
Confidence Interval (2-Sided) 95%
-20.14 to -2.28
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Fever Clearance Time
Hide Description Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral).
Time Frame Baseline to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, including participants in the Ivory Coast center.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 124 131
Median (Full Range)
Unit of Measure: Hours
24.000
(1 to 504)
24.000
(1 to 336)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Time to event data was analyzed using the Kaplan-Meier curve.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2564
Comments [Not Specified]
Method Kaplan-Meier, log rank
Comments [Not Specified]
16.Secondary Outcome
Title Asexual Plasmodium Falciparum Parasite Clearance Time
Hide Description Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Time Frame Baseline to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, including participants in the Ivory Coast center.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 124 131
Median (Full Range)
Unit of Measure: Hours
48.000
(24 to 504)
24.000
(1 to 48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Time to event data was analyzed using the Kaplan-Meier curve.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kaplan-Meier, log rank
Comments [Not Specified]
17.Secondary Outcome
Title Nadir Hemoglobin Level
Hide Description Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.
Time Frame Day 0 through Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, including participants in the Ivory Coast center.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 124 131
Mean (Standard Deviation)
Unit of Measure: grams per deciliter (g/dL)
9.63  (1.53) 9.82  (1.61)
18.Secondary Outcome
Title Change From Nadir Hemoglobin Level at Days 14, 28, and 42
Hide Description Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.
Time Frame Day 14, 28, 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. "N" = number of participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 122 128
Mean (Standard Error)
Unit of Measure: g/dL
Change at Day 14 (n=122, 127) 0.52  (0.11) 0.44  (0.13)
Change at Day 28 (n=122, 127) 1.15  (0.11) 0.96  (0.13)
Change at Day 42 (n=122, 128) 1.29  (0.12) 1.14  (0.14)
19.Secondary Outcome
Title Time to Recurrence of Parasitemia
Hide Description Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).
Time Frame Baseline (Day 0) to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, including participants in the Ivory Coast center.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 124 131
Median (Full Range)
Unit of Measure: Days
34
(2 to 42)
NA [1] 
(7 to 43)
[1]
Median time to recurrence could not be calculated for participants in the Artemether-Lumefantrine treatment groups since fewer than 50% of the participants experienced recurrent parasitemia during the study.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: Azithromycin + Chloroquine, Cohort 2: Artemether + Lumefantrine
Comments Time to event data was analyzed using the Kaplan-Meier curve.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Kaplan-Meier, log rank
Comments [Not Specified]
20.Secondary Outcome
Title Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status
Hide Description [Not Specified]
Time Frame Baseline to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed as per change in planned analysis.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Percentage of Participants With PfCRT in True Failures
Hide Description A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.
Time Frame Baseline to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed as per change in planned analysis.
Arm/Group Title Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description:
Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Cohort 1: Azithromycin + Chloroquine Cohort 1: Artemether + Lumefantrine Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Hide Arm/Group Description Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between >=5 years of age and <=12 years of age. Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age. Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age. Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
All-Cause Mortality
Cohort 1: Azithromycin + Chloroquine Cohort 1: Artemether + Lumefantrine Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Azithromycin + Chloroquine Cohort 1: Artemether + Lumefantrine Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/55 (1.82%)   2/51 (3.92%)   0/124 (0.00%)   1/131 (0.76%) 
Infections and infestations         
Hepatitis B * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Malaria * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Sepsis * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Nervous system disorders         
Convulsion * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: Azithromycin + Chloroquine Cohort 1: Artemether + Lumefantrine Cohort 2: Azithromycin + Chloroquine Cohort 2: Artemether + Lumefantrine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/55 (72.73%)   36/51 (70.59%)   103/124 (83.06%)   99/131 (75.57%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/55 (0.00%)  1/51 (1.96%)  2/124 (1.61%)  4/131 (3.05%) 
Lymphadenopathy * 1  0/55 (0.00%)  1/51 (1.96%)  1/124 (0.81%)  0/131 (0.00%) 
Splenomegaly * 1  0/55 (0.00%)  3/51 (5.88%)  1/124 (0.81%)  0/131 (0.00%) 
Thrombocytopenia * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Cardiac disorders         
Atrioventricular block first degree * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Tachycardia * 1  0/55 (0.00%)  1/51 (1.96%)  1/124 (0.81%)  1/131 (0.76%) 
Congenital, familial and genetic disorders         
Phimosis * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Ear and labyrinth disorders         
Ear pain * 1  1/55 (1.82%)  2/51 (3.92%)  0/124 (0.00%)  0/131 (0.00%) 
Eye disorders         
Conjunctival pallor * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Conjunctivitis * 1  0/55 (0.00%)  3/51 (5.88%)  3/124 (2.42%)  2/131 (1.53%) 
Eye swelling * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Periorbital oedema * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Gastrointestinal disorders         
Abdominal distension * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Abdominal pain * 1  10/55 (18.18%)  5/51 (9.80%)  4/124 (3.23%)  14/131 (10.69%) 
Abdominal pain upper * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Diarrhoea * 1  2/55 (3.64%)  1/51 (1.96%)  4/124 (3.23%)  8/131 (6.11%) 
Nausea * 1  3/55 (5.45%)  2/51 (3.92%)  0/124 (0.00%)  1/131 (0.76%) 
Vomiting * 1  11/55 (20.00%)  5/51 (9.80%)  38/124 (30.65%)  13/131 (9.92%) 
Anal pruritus * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  1/131 (0.76%) 
Colitis * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Enteritis * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  2/131 (1.53%) 
Gastrointestinal sounds abnormal * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  0/131 (0.00%) 
Mucous stools * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  1/131 (0.76%) 
Stomatitis * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
General disorders         
Chills * 1  2/55 (3.64%)  2/51 (3.92%)  3/124 (2.42%)  5/131 (3.82%) 
Fatigue * 1  1/55 (1.82%)  2/51 (3.92%)  0/124 (0.00%)  3/131 (2.29%) 
Feeling hot * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Malaise * 1  0/55 (0.00%)  1/51 (1.96%)  3/124 (2.42%)  2/131 (1.53%) 
Pyrexia * 1  4/55 (7.27%)  3/51 (5.88%)  17/124 (13.71%)  27/131 (20.61%) 
Chest pain * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  3/131 (2.29%) 
Inflammation * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Irritability * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Product taste abnormal * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  0/131 (0.00%) 
Infections and infestations         
Abscess limb * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  1/131 (0.76%) 
Body tinea * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  1/131 (0.76%) 
Bronchitis * 1  1/55 (1.82%)  0/51 (0.00%)  4/124 (3.23%)  9/131 (6.87%) 
Dysentery * 1  0/55 (0.00%)  1/51 (1.96%)  1/124 (0.81%)  1/131 (0.76%) 
Giardiasis * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Infection parasitic * 1  14/55 (25.45%)  11/51 (21.57%)  37/124 (29.84%)  31/131 (23.66%) 
Malaria * 1  5/55 (9.09%)  4/51 (7.84%)  26/124 (20.97%)  19/131 (14.50%) 
Oral herpes * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Otitis media acute * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  1/131 (0.76%) 
Rhinitis * 1  2/55 (3.64%)  1/51 (1.96%)  2/124 (1.61%)  1/131 (0.76%) 
Skin infection * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Tinea capitis * 1  5/55 (9.09%)  2/51 (3.92%)  2/124 (1.61%)  2/131 (1.53%) 
Tonsillitis * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Upper respiratory tract infection * 1  6/55 (10.91%)  4/51 (7.84%)  9/124 (7.26%)  12/131 (9.16%) 
Urinary tract infection * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Amoebiasis * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Bacterial infection * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  1/131 (0.76%) 
Blister infected * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Bronchopneumonia * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  2/131 (1.53%) 
Ear infection * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  1/131 (0.76%) 
Fungal skin infection * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  2/131 (1.53%) 
Furuncle * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  5/131 (3.82%) 
Gastroenteritis * 1  0/55 (0.00%)  0/51 (0.00%)  2/124 (1.61%)  5/131 (3.82%) 
Helminthic infection * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Hepatitis A * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Mumps * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  1/131 (0.76%) 
Otitis media * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  1/131 (0.76%) 
Pneumonia * 1  0/55 (0.00%)  0/51 (0.00%)  2/124 (1.61%)  0/131 (0.00%) 
Respiratory tract infection * 1  0/55 (0.00%)  0/51 (0.00%)  2/124 (1.61%)  8/131 (6.11%) 
Septic rash * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Staphylococcal skin infection * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Subcutaneous abscess * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Viral rash * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  0/131 (0.00%) 
Injury, poisoning and procedural complications         
Scratch * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Wound * 1  0/55 (0.00%)  2/51 (3.92%)  2/124 (1.61%)  1/131 (0.76%) 
Thermal burn * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Investigations         
Electrocardiogram QT prolonged * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  3/55 (5.45%)  3/51 (5.88%)  9/124 (7.26%)  5/131 (3.82%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Musculoskeletal pain * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Myalgia * 1  1/55 (1.82%)  1/51 (1.96%)  0/124 (0.00%)  1/131 (0.76%) 
Pain in extremity * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Nervous system disorders         
Dizziness * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Headache * 1  8/55 (14.55%)  5/51 (9.80%)  4/124 (3.23%)  4/131 (3.05%) 
Psychiatric disorders         
Restlessness * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Reproductive system and breast disorders         
Balanoposthitis * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Vaginal inflammation * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  0/131 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  3/55 (5.45%)  6/51 (11.76%)  15/124 (12.10%)  13/131 (9.92%) 
Epistaxis * 1  3/55 (5.45%)  0/51 (0.00%)  1/124 (0.81%)  0/131 (0.00%) 
Oropharyngeal pain * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Rhinorrhoea * 1  0/55 (0.00%)  1/51 (1.96%)  4/124 (3.23%)  2/131 (1.53%) 
Dyspnoea * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  0/131 (0.00%) 
Nasal congestion * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Tachypnoea * 1  0/55 (0.00%)  0/51 (0.00%)  1/124 (0.81%)  1/131 (0.76%) 
Skin and subcutaneous tissue disorders         
Blister * 1  0/55 (0.00%)  1/51 (1.96%)  0/124 (0.00%)  0/131 (0.00%) 
Pruritus * 1  9/55 (16.36%)  1/51 (1.96%)  8/124 (6.45%)  2/131 (1.53%) 
Pruritus generalised * 1  2/55 (3.64%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
Swelling face * 1  1/55 (1.82%)  1/51 (1.96%)  1/124 (0.81%)  0/131 (0.00%) 
Urticaria * 1  1/55 (1.82%)  0/51 (0.00%)  1/124 (0.81%)  0/131 (0.00%) 
Dermatitis atopic * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Rash * 1  0/55 (0.00%)  0/51 (0.00%)  2/124 (1.61%)  2/131 (1.53%) 
Rash generalised * 1  0/55 (0.00%)  0/51 (0.00%)  2/124 (1.61%)  0/131 (0.00%) 
Rash papular * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Skin ulcer * 1  0/55 (0.00%)  0/51 (0.00%)  0/124 (0.00%)  1/131 (0.76%) 
Vascular disorders         
Pallor * 1  1/55 (1.82%)  0/51 (0.00%)  0/124 (0.00%)  0/131 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Cohort 1 was a screening cohort, meant for safety evaluation, but not included in the efficacy assessments.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00677833     History of Changes
Other Study ID Numbers: A0661157
First Submitted: May 12, 2008
First Posted: May 15, 2008
Results First Submitted: May 27, 2014
Results First Posted: June 26, 2014
Last Update Posted: June 26, 2014