NCT00709969

Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Artemether-lumefantrine	20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - \< 10kg (BWG 1) = 6 doses of 1 tablet / 10 - \< 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets

Timeline

• Start date: 2002-07-01
• Completion: 2003-02-01
• First posted: 2008-07-03
• Last updated: 2008-07-03

Locations

3 sites across 3 countries: Kenya, Nigeria, Tanzania