Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil (PAACT-PF)
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.
Drug: Mefloquine- Artesunate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 63-day PCR-adjusted parasitological cure of P. falciparum [ Time Frame: 63 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Mefloquine- Artesunate
Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Drug: Mefloquine- Artesunate
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Other Name: Mefloquine- Artesunate (Farmaguinhos, Brazil)
Active Comparator: Artemether- Lumefantrine
Artemether-Lumefantrine: 4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082731
|Hospital Geral Maternidade de Cruzeiro do Sul|
|Cruzeiro do Sul, Acre, Brazil|
|Centro de Pesquisa em Patologias Tropicais|
|Porto Velho, Rondonia, Brazil|
|Principal Investigator:||Meghna Desai, PhD MPH||Centers for Disease Control and Prevention|