Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children

PHASE3CompletedINTERVENTIONAL
Enrollment

4,112

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
FeverMalaria
Interventions
DRUG

amodiaquine-artesunate (ASAQ)

A fix-dose combination tablet containing artesunate-amodiaquine in three different dosages, to be used according to patient age and weight: 25mg/67.5mg; 50mg/135mg; 100mg/270mg

DRUG

dihydroartemisinin-piperaquine (DHAPQ)

DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively.

DRUG

artemether-lumefantrine (AL)

Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.

DRUG

Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)

"Lapdap tablets contain 15/18.75mg or 80/100mg of Chlorproguanil Hydrochloride and Dapsone, respectively. Arsumax® tablets contain 50mg Artesunate.~TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008."

Trial Locations (8)

Unknown

Centre Muraz/IRSS, Bobo-Dioulasso

Albert Schweitzer Hospital, Lambaréné

Manhiça Health Research Center, Manhiça

Hospital, Calabar

Mashshesha and Rukara, Kigali

Jinja and Tororo, Kampala

Mbarara,, Mbarara

Tropical Diseases Research Centre, P O Box 71769,, Ndola

All Listed Sponsors
collaborator

Liverpool School of Tropical Medicine

OTHER

collaborator

East African Network for Monitoring Antimalarial Treatment

NETWORK

collaborator

Centre Muraz

OTHER

collaborator

University of Calabar

OTHER

collaborator

Tropical Diseases Research Centre, Zambia

OTHER_GOV

collaborator

University Hospital Tuebingen

OTHER

collaborator

Albert Schweitzer Hospital

OTHER

collaborator

Uganda Malaria Surveillance Project

OTHER

collaborator

Mbarara University of Science and Technology

OTHER

collaborator

Ministry of Health, Rwanda

OTHER_GOV

collaborator

University of Barcelona

OTHER

collaborator

Centro de Investigacao em Saude de Manhica

OTHER

lead

Institute of Tropical Medicine, Belgium

OTHER

NCT00393679 - Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children | Biotech Hunter | Biotech Hunter