Treatment Latin America
Title: The efficacy of Artemether-Lumefantrine (Coartem) and Mefloquine-Artesunate for the treatment of uncomplicated P. falciparum malaria parasitemia in pregnant women in Latin America
Project Coordinator(s): Meghna Desai and Julie Gutman (USA) and Clara Menendez (Spain)
Centro de Pesquisa em Medicina Tropical (CEMETRON), Porto Velho
Fundação de Medicina Tropical do Amazonas, Coari
Instituto Evandro Chagas, Anajas
Hospital General de Jurau, Cruzeiro do Sul
About 30% of the nearly 900 million inhabitants of the Americas live in areas at risk for malaria transmission; pregnant women are more likely to become infected with malaria than other adults living in the same areas. It is estimated that about 4% of pregnancies in Latin America (Central and South America and the Caribbean) are affected with malaria. Malaria in pregnancy is a major cause of maternal morbidity and poor birth outcomes. In areas of low transmission, such as Latin America, women may present with symptomatic malaria, manifesting with fever, cerebral malaria, respiratory distress syndrome, premature delivery, or abortion. However, many pregnant women will have subclinical infections, which can cause moderate to severe maternal anaemia that is in turn associated with low birthweight infants, adverse effects on lactation, and increased rates of miscarriage and stillbirth.
Although malaria in pregnancy can have serious consequences for both the mother and the fetus, very little information is available on the true burden of malaria in pregnancy in Latin America, and even less information is available on the best treatments for malaria in pregnancy.
The treatment recommendations for MiP in Latin American countries have been changing rapidly in recent months; currently, either artemether-lumefantrine or mefloquine-artesunate 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 this area to support their use. Furthermore, several small studies have suggested that the normal adult doses result in under-dosing when applied to pregnant women.
We will be conducting a clinical trial at 4 sites in the Brazilian Amazon (Porto Velho, Coari, Anajas and Cruzeiro do Sul) to assess the safety and efficacy of the present therapies, artemether-lumefantrine (Coartem) and mefloquine-artesunate. We will also be collecting additional data on the drug levels in pregnant women which will help to determine the optimal dose for use in pregnancy. This study will provide crucial data to allow effective treatment of malaria in pregnant women in Latin America and other low transmission settings.