In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique — MEFI_IV  

Malaria Clinical Trial

Official title: Monitoring the Therapeutic Efficacy of the Combinations Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 5 Years of Age in Five Sentinel Sites in Mozambique

Status Active, not recruiting

Clinical Trial Summary

This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in 5 sites of the four oral ACTS artemether-lumefantrine (AL), Amodiaquine-Artesunate (AQ-AS), Dihydroartemisinin-Piperaquine (DHP) and Pironaridine-Artesunate for the treatment of uncomplicated malaria in children aged<5 years.

Clinical Trial Description

Eligible patients were consecutively assigned to the cohort and treated with AL (cohort 1), AQ-AS (cohort 2), DHP (cohort 3) and PA (cohort 4). AL (Coartem™) will be administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to <15kg, two tablets per dose for those 15 to <25kg, and three tablets per dose for those 25 to <35kg. AQ-AS (Winthrop™) will be administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children <9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children >18-35kg. DHP will be administered once daily according to body weight: half tablet (40mg dihydroartemisinin e 320 mg piperaquine) for children 5 to < 10Kg, one tablet for per dose for those 10 < 20Kg and 2 tablets for 20 or more Kg. PA (granules 60mg pirinaridine +/20mg artesunate) will administered once daily according to body weight: 1 granule per dose for children 5 to < 8Kg, two for children 8 < 15Kg, three for those 15 < 20Kg. PA (180mg pyrinaridine+60 mg artesunate) one tablet for children 20 < 24Kg and two tablets for those 24 < 45Kg. All treatments will be directly observed for a minimum of 30 minutes. Vomiting occurring within the first 30 minutes implied the repetition of the full dose of treatment. For those patients living far away from the health facilities, and for which direct observation of the evening doses of AL was challenging, admission was offered for the first three days of the study. ;

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT05343312
• Study type: Interventional
• Source: Centro de Investigacao em Saude de Manhica
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 16, 2022
• Completion date: July 30, 2024