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NCT01082731TERMINATEDanonymous

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

Sponsor

Source record

Centers for Disease Control and Prevention

Phase

Source record

PHASE4

Modality

AI-normalized

small molecule

Target

AI-normalized

Artemether-Lumefantrine, Mefloquine- Artesunate

Indication / condition

AI-normalized

Malaria

Intervention

Source record

Artemether-Lumefantrine, Mefloquine- Artesunate

Source & freshness

Source record

NCT ID

NCT01082731

Original source

ClinicalTrials.gov

Source last updated

Apr 13, 2012

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT01082731

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

Sponsor

Centers for Disease Control and Prevention

Status

TERMINATED

Phase

PHASE4

Condition raw

Malaria

Condition normalized

Malaria

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Artemether-Lumefantrine, Mefloquine- Artesunate

Target normalized

Artemether-Lumefantrine, Mefloquine- Artesunate

Interventions

Artemether-Lumefantrine, Mefloquine- Artesunate

Public preview

Source record

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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