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

PHASE3CompletedINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

July 31, 2002

Study Completion Date

February 28, 2003

Conditions
Plasmodium Falciparum Malaria
Interventions
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

Trial Locations (3)

Unknown

Kemri-Wellcome Trust Programme, Kilifi

University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training, Ibadan

Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011, Dar es Salaam

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

World Health Organization

OTHER

collaborator

Avenue Appia 20

UNKNOWN

collaborator

CH - 1211 Geneva 27

UNKNOWN

collaborator

Switzerland

UNKNOWN

lead

Novartis

INDUSTRY