Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil
Status:
Terminated
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
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.