Clinical trial NCT00367653: Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
Official title: A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: duration of trial
measure: 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.
timeFrame: duration of trial
Secondary outcomes:
measure: A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
timeFrame: duration of trial
measure: Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
timeFrame: duration of trial
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Pfizer Investigational Site
state: West Africa
city: Nouna
country: Burkina Faso
facility: Pfizer Investigational Site
city: Navrongo
country: Ghana
facility: Pfizer Investigational Site
state: West Africa
city: Kisumu
country: Kenya
facility: Pfizer Investigational Site
city: Bamako
country: Mali
facility: Pfizer Investigational Site
state: West Africa
city: Bamako
country: Mali
facility: Pfizer Investigational Site
city: Senegal
country: Senegal
facility: Pfizer Investigational Site
state: West Africa
city: Ndola
country: Zambia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimde AA, Sarkar S, Chandra R, Robbins J, Dunne MW. Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults. Malar J. 2014 Nov 25;13:458. doi: 10.1186/1475-2875-13-458.