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NCT00852423COMPLETEDanonymous

Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria

Sponsor

Source record

Institute of Tropical Medicine, Belgium

Phase

Source record

PHASE3

Modality

AI-normalized

small molecule

Target

AI-normalized

Dihydroartemisinin-piperaquine, Artesunate-mefloquine, Artesunate-amodiaquine, Artemether-lumefantrine

Indication / condition

AI-normalized

Malaria in Pregnancy

Intervention

Source record

Dihydroartemisinin-piperaquine, Artesunate-mefloquine, Artesunate-amodiaquine, Artemether-lumefantrine

Source & freshness

Source record

NCT ID

NCT00852423

Original source

ClinicalTrials.gov

Source last updated

Mar 14, 2016

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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NCT ID

NCT00852423

Title

Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria

Sponsor

Institute of Tropical Medicine, Belgium

Status

COMPLETED

Phase

PHASE3

Condition raw

Malaria in Pregnancy

Condition normalized

Malaria in Pregnancy

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Dihydroartemisinin-piperaquine, Artesunate-mefloquine, Artesunate-amodiaquine, Artemether-lumefantrine

Target normalized

Dihydroartemisinin-piperaquine, Artesunate-mefloquine, Artesunate-amodiaquine, Artemether-lumefantrine

Interventions

Dihydroartemisinin-piperaquine, Artesunate-mefloquine, Artesunate-amodiaquine, Artemether-lumefantrine

Public preview

Source record

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 always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.

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