Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Drug: Azithromycin plus Chloroquine; Drug: Mefloquine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367653

A0661155

Details and patient eligibility

About

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

Enrollment: 397 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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397 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Azithromycin plus Chloroquine

2

Experimental group

Treatment:

Drug: Mefloquine