Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

PHASE3CompletedINTERVENTIONAL
Enrollment

2,117

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Malaria
Interventions
DRUG

Artemether/Lumefantrine

"Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).~Weight in kg Number of tablet per dose Age 5 to \< 15 kg 1 tablet per dose 15 to \< 25 kg 2 tablets per dose 25 to \< 35 kg 3 tablets per dose"

DRUG

Artesunate/Amodiaquine

"Age (Weight in Kg) Dose Treatment duration 2 to 11 months (= 4,5 to \< 9kg):1 tablet (25 mg/675mg) for 3 days~1 to 5 years (= 9 kg to \< 18 kg)1 tablet(25mg/67,5mg)for 3 days"

DRUG

Quinine + Clindamycin

"this arm consist to 7 days treatment of 60 patients with quinine tablet 125mg + clindamycin syrup as follow;~Quinine:~9 to \< 11 kg: ½ tablets 12 to \< 19 kg: 1 tablets per dose 20 to \< 27 kg: 1½ tablets per dose 28 to \< 35 kg: 2 tablets per dose~Clindamycin syrup:~10 mg/kg twice daily"

Trial Locations (2)

Route Kimwenza n°23

Centre de Santé Lisungi, Kinshasa

P.O Box 5 Rushere

Kazo Health centre IV, Kiruhura

All Listed Sponsors
collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

Fund for Scientific Research, Flanders, Belgium

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

University of Kinshasa

OTHER

collaborator

Centre Muraz

OTHER

collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

collaborator

Makerere University

OTHER

lead

Universiteit Antwerpen

OTHER

NCT01374581 - Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria | Biotech Hunter | Biotech Hunter