To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
397
Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
Mefloquine 1250 mg PO given as a split dose (750 mg \[three 250 mg capsules\]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
Pfizer Investigational Site
Ouagadougou, West Africa, Burkina Faso
Pfizer Investigational Site
Nouna, Burkina Faso
Pfizer Investigational Site
Navrongo, West Africa, Ghana
Pfizer Investigational Site
Kisumu, Kisumu County, Kenya
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.
Time frame: 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.
Time frame: duration of trial
A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
Time frame: duration of trial
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
Time frame: duration of trial
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pfizer Investigational Site
Bamako, West Africa, Mali
Pfizer Investigational Site
Bamako, Mali
Pfizer Investigational Site
Senegal, West Africa, Senegal
Pfizer Investigational Site
Ndola, Zambia