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

Phase 2

Completed

• Conditions: Falciparum Malaria
• Interventions: Drug: Azithromycin plus chloroquine

• Registration Number: NCT00282919
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-27
• Study Start: 2006-03
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Disposition First Submitted: 2009-08-12
• Disposition First Submitted QC: 2009-08-12
• Disposition First Posted: 2009-08-14
• Status Verified: 2014-05
• Results First Submitted: 2014-05-27
• Results First Submitted QC: 2014-05-27
• Last Update Submitted: 2014-05-27
• Results First Posted: 2014-06-26
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

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Exclusion Criteria

• Subjects with severe or complicated malaria. Pregnant or breast feeding women.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azithromycin plus chloroquine	Azithromycin plus chloroquine	Single Arm, Open label study

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Parasite Clearance at Day 28	Day 28	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Late Treatment Failures (LTF)	Baseline up to Day 28	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 Parasite Clearance at Day 7, 14, 21, 35, 42	Day 7, 14, 21, 35, 42	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 Early Treatment Failures (ETF)	Baseline up to Day 28	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 Resistance to Treatment	Days 7, 14, 21, 28, 35, 42	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	Day 3, 7, 28, and 42	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 Gametocyte Clearance	Day 7, 14, 21, 28, 35, 42	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	Baseline up to Day 42	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	Baseline up to Day 42	Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 Bambolim, Goa, India