Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria

PHASE4CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Malaria, Falciparum
Interventions
DRUG

Artemether/lumefantrine tablets

"Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine~Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets~Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2"

DRUG

Artemether/Lumefantrine suspension

"Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension~Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml~Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2"

Trial Locations (1)

40100

Chulaimbo Health Centre, Kisumu

Sponsors
All Listed Sponsors
collaborator

Kenya Medical Research Institute

OTHER

lead

Dafra Pharma

INDUSTRY