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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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Artemether-Lumefantrine, Mefloquine- Artesunate
Hospital Geral Maternidade de Cruzeiro do Sul
Cruzeiro do Sul
Not yet recruiting
Centers for Disease Control and Prevention
Published on BioPortfolio: 2014-08-27T03:15:23-0400
To evaluate the potential effects of artemether- lumefantrine on the auditory function
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Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost a...
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The fixed dose combination of artemether-lumefantrine (AL) is the most widely used treatment for uncomplicated Plasmodium falciparum malaria. Relatively lower cure rates and lumefantrine levels have b...
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Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.
Vaccines made from antigens arising from any of the four strains of Plasmodium which cause malaria in humans, or from P. berghei which causes malaria in rodents.
A protozoan parasite that causes vivax malaria (MALARIA, VIVAX). This species is found almost everywhere malaria is endemic and is the only one that has a range extending into the temperate regions.
Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.
A protozoan parasite that occurs naturally in the macaque. It is similar to PLASMODIUM VIVAX and produces a type of malaria similar to vivax malaria (MALARIA, VIVAX). This species has been found to give rise to both natural and experimental human infections.
Malaria is a serious tropical disease spread by mosquitoes. If malaria is not diagnosed and treated promptly, it can be fatal. What causes malaria? Malaria is caused by a type of parasite known as Plasmodium. There are many different types of Plasmod...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...