Malaria Clinical Trial
Official title:
A Multi-center, Open-label, Randomized, Phase 4, Trial of Artemether-Lumefantrine and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Falciparum Malaria Parasitemia in Pregnant Women in Brazil
Data on the burden of MIP in low transmission areas, such as Latin America, are very
limited; there is even less information on the efficacy of case management of MiP. The
treatment recommendations for MiP in Latin American countries have been changing rapidly in
recent months; currently, either artemether-lumefantrine (AL) or mefloquine-artesunate (MA)
is the first line treatment for P. falciparum (depending on country); however, no data
exists on the efficacy of these drugs for the treatment of malaria in pregnancy in Latin
America to support their use.
We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess
safety and efficacy of the present therapies, AL and MA. We hypothesize that the drugs will
both be efficacious for use in pregnant women in Brazil.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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