drugset / Trial / NCT04897919

Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for Treating Malaria

NCT04897919

Phase 4 Completed 474 enrolled Bandim Health Project
RandomizedParallel-groupOpen-labelTreatment

Summary

Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (\> 6 months) suffering from uncomplicated P. falciparum malaria. Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed. Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.

Timeline

Start
2015-08-01
Primary completion
2017-10-01
Completion
2018-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Artemether-lumefantrine Unknown 20 mg Oral
Comparator Artemether-lumefantrine Unknown 120 mg Oral
Subject Dihydroartemisinin-piperaquine Unknown 20 mg Oral
Subject Dihydroartemisinin-piperaquine Unknown 160 mg Oral

Indications