Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania

Phase 2 Completed 201 enrolled London School of Hygiene and Tropical Medicine Kilimanjaro Christian Medical Centre, Tanzania · collab National Institute for Medical Research, Tanzania · collab

RandomizedParallel-groupSingle-blindBasic science

Summary

Sulfadoxine-pyrimethamine (SP) is currently recommended by the World Health Organization for use as intermittent preventive treatment against malaria in pregnancy (IPTp) in areas of moderate to high malaria transmission. However, in some locales malaria parasites have lost sensitivity to SP, compromising its protective effect. Dihydroartemisinin-piperaquine (DP) is a candidate replacement for SP. This trial is designed to confirm the cardio-safety of DP compared to SP amongst pregnant women in Tanzania.

Timeline

Start: 2016-09
Primary completion: 2020-01
Completion: 2020-02

Publications

Background Food and Drug Administration, HHS. International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice. Fed Regist. 2005 Oct 20;70(202):61134-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARTENIMOL	Small molecule	120 mg	—
Subject	piperaquine	Small molecule	960 mg	—
Comparator	pyrimethamine	Small molecule	25 mg	—
Comparator	sulfadoxine	Small molecule	500 mg	—

Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania

Summary

Timeline

Publications

Drugs

Indications