TrialSignal
Clinical trial intelligence report
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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 13, 2026
NCT ID
NCT01082731
Status
TERMINATED
Phase
PHASE4
Sponsor
Centers for Disease Control and Prevention
Executive brief
Investment-Ready Snapshot
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.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT01082731
Indication
Malaria
Modality
small molecule
Target
Artemether-Lumefantrine, Mefloquine- Artesunate
Intervention
Artemether-Lumefantrine, Mefloquine- Artesunate
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.