Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil
- Conditions
- Malaria
- Interventions
- Registration Number
- NCT01082731
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 6
- Gestational age >16 weeks (determined by LMP and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus
- Normal fetal heart beat detected by Doppler
- Presence of any P. falciparum parasitemia ≤ 50,000 parasites/microliter (thick film)
- Willing to sign or thumb print informed consent
- Willing to return for scheduled follow up visits for treatment and observation until delivery
- Willing to deliver in health facility
- Pregnancy < 16 weeks
- Microscopically confirmed P. vivax or mixed infection/ parasitemia (P. falciparum and another species of Plasmodium, i.e. P. vivax, P. ovale, or P. malariae)
- History of allergy or hypersensitivity to interventional drugs
- Exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including AL and MA)
- Patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin)
- History or family history of epilepsy or psychiatric disorder
- Presence of signs and symptoms of severe malaria
- Hemoglobin < 7 g/dl
- Inability to tolerate oral medication (repeated vomiting, impairment of consciousness).
- History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, HIV or AIDS, known hemoglobinopathy
- Participant's inability to return for follow up visits
- Age <15 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mefloquine- Artesunate Mefloquine- Artesunate Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days. Artemether- Lumefantrine 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
- Primary Outcome Measures
Name Time Method 63-day PCR-adjusted parasitological cure of P. falciparum 63 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hospital Geral Maternidade de Cruzeiro do Sul
🇧🇷Cruzeiro do Sul, Acre, Brazil
Centro de Pesquisa em Patologias Tropicais
🇧🇷Porto Velho, Rondonia, Brazil