A Phase 3 interventional study of Azithromycin plus Chloroquine and Mefloquine in Malaria, sponsored by Pfizer. Completed at 8 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-16.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 397 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Drug: Azithromycin plus Chloroquine
Drug: Mefloquine
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)
Also known as: Zithromax
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
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 study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Pfizer