Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
- Registration Number
- NCT00367653
- Lead Sponsor
- Pfizer
- Brief Summary
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 397
Inclusion Criteria
- Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
- Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
- Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.
Exclusion Criteria
- Severe or complicated malaria.
- Pregnant or breast-feeding women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Azithromycin plus Chloroquine - 2 Mefloquine -
- Primary Outcome Measures
Name Time Method The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa. duration of trial The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population. duration of trial
- Secondary Outcome Measures
Name Time Method A secondary objective is to assess the efficacy of azithromycin plus chloroquine. duration of trial Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens. duration of trial
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇿🇲Ndola, Zambia