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Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

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ClinicalTrials.gov Identifier: NCT01619878
Recruitment Status : Completed
First Posted : June 14, 2012
Results First Posted : June 17, 2015
Last Update Posted : June 17, 2015
Sponsor:
Collaborator:
Medicines for Malaria Venture
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Uncomplicated Falciparum Malaria
Intervention Drug: Artemether-lumefantrine (COA566)
Enrollment 20
Recruitment Details The participant that did not complete in the "6 week follow-up phase" was also included in "Follow-up at 12 Months of Age" and was lost to follow-up
Pre-assignment Details  
Arm/Group Title Cohort 1
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One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Period Title: 6 Week Follow-up Phase
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Adverse Event             1
Period Title: Follow-up at 12 Months of Age
Started 20
Completed 17
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Death             2
Arm/Group Title Cohort 1
Hide Arm/Group Description

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 20 participants
99.1  (51.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
1.Primary Outcome
Title Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
Hide Description Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: number of participants
16
2.Secondary Outcome
Title Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42
Hide Description Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
Time Frame Day 14 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Number of participants
Day 14 16
Day 42 16
3.Secondary Outcome
Title Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42
Hide Description Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.
Time Frame Day 3, 7, 14, 28 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Day 3 20
Day 7 16
Day 14 16
Day 28 10
Day 42 7
4.Secondary Outcome
Title Percent Change of Parasite Count From Baseline at 24 Hours
Hide Description Percent change of parasite count from baseline at 24 hours
Time Frame baseline, 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Percent Change
-99.4  (1.19)
5.Secondary Outcome
Title Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline
Hide Description Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline
Hide Description Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
7.Secondary Outcome
Title Time to Parasite Clearance (PCT)
Hide Description Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hours
29.1  (9.6)
8.Secondary Outcome
Title Time to Fever Clearance (FCT)
Hide Description Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hours
4.02  (6.433)
9.Secondary Outcome
Title Time to Gametocyte Clearance (GCT)
Hide Description Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.
Arm/Group Title Cohort 1
Hide Arm/Group Description:

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hours
36.32  (77.294)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1
Hide Arm/Group Description

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age >28 days.

All-Cause Mortality
Cohort 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1
Affected / at Risk (%)
Total   3/20 (15.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/20 (5.00%) 
Gastrointestinal disorders   
Diarrhoea  1  1/20 (5.00%) 
General disorders   
Death  1  1/20 (5.00%) 
Infections and infestations   
Cerebral malaria  1  1/20 (5.00%) 
Meningitis  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1
Affected / at Risk (%)
Total   16/20 (80.00%) 
Blood and lymphatic system disorders   
Anaemia  1  6/20 (30.00%) 
Gastrointestinal disorders   
Enteritis  1  1/20 (5.00%) 
Vomiting  1  4/20 (20.00%) 
General disorders   
Pyrexia  1  5/20 (25.00%) 
Infections and infestations   
Bronchitis  1  6/20 (30.00%) 
Gastroenteritis  1  2/20 (10.00%) 
Malaria  1  11/20 (55.00%) 
Rash pustular  1  1/20 (5.00%) 
Rhinitis  1  2/20 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01619878     History of Changes
Other Study ID Numbers: CCOA566B2306
2011-005852-33
2011-005858-33 ( Other Identifier: Eudra CT )
First Submitted: June 12, 2012
First Posted: June 14, 2012
Results First Submitted: May 11, 2015
Results First Posted: June 17, 2015
Last Update Posted: June 17, 2015