NCT00393679

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,112 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) \[amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate\] for single and repeat treatments of uncomplicated malaria in children. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms. 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 approved the amendment on 2nd June 2008. TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.

Conditions

• Fever
• Malaria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-10-30
• Last updated: 2014-02-03

Locations

8 sites across 7 countries: Burkina Faso, Gabon, Mozambique, Nigeria, Rwanda, Uganda, Zambia