Malaria
Conditions
Brief summary
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
Interventions
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)
DRUGMefloquine
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
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Burkina Faso, Ghana, Kenya, Mali, Senegal, Zambia
Outcome results
None listed