A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00282919
First received: January 26, 2006
Last updated: May 27, 2014
Last verified: May 2014

January 26, 2006
May 27, 2014
March 2006
February 2008   (final data collection date for primary outcome measure)
Percentage of Participants With Parasite Clearance at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
To confirm the hypothesis that a dose of 2000 mg Azithromycin plus 600 mg chloroquine base each day for three days is highly efficacious for the treatment of symptomatic, uncomplicated P. falciparum.
Complete list of historical versions of study NCT00282919 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Early Treatment Failures (ETF) [ Time Frame: Baseline up to Day 28 ] [ Designated as safety issue: No ]
    ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline).
  • Percentage of Participants With Late Treatment Failures (LTF) [ Time Frame: Baseline up to Day 28 ] [ Designated as safety issue: No ]
    LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.
  • Percentage of Participants With Resistance to Treatment [ Time Frame: Days 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
    Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported.
  • Percentage of Participants With Clinical Cure [ Time Frame: Day 3, 7, 28, and 42 ] [ Designated as safety issue: No ]
    Clinical Cure is defined as resolution of the participant's fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).
  • Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42 [ Time Frame: Day 7, 14, 21, 35, 42 ] [ Designated as safety issue: No ]
    Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
  • Percentage of Participants With Gametocyte Clearance [ Time Frame: Day 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
    Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported.
  • Fever Clearance Time [ Time Frame: Baseline up to Day 42 ] [ Designated as safety issue: No ]
    Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature).
  • Parasite Clearance Time [ Time Frame: Baseline up to Day 42 ] [ Designated as safety issue: No ]
    Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.
An assessment of the safety and tolerability of the treatment regimen.
Not Provided
Not Provided
 
A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
A Phase 2, Open Label, Non-Comparative Trial Of Azithromycin 2000 mg Plus Chloroquine 600 Mg Base Daily For Three Days For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria

The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Falciparum Malaria
Drug: Azithromycin plus chloroquine
dose of 2000 mg Azithromycin plus 600 mg chloroquine base
Experimental: Azithromycin plus chloroquine
Single Arm, Open label study
Intervention: Drug: Azithromycin plus chloroquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.

Exclusion Criteria:

  • Subjects with severe or complicated malaria. Pregnant or breast feeding women.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   India
 
NCT00282919
A0661154
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP