Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children
Condition: Fever; Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): amodiaquine-artesunate (ASAQ); dihydroartemisinin-piperaquine (DHAPQ); artemether-lumefantrine (AL); Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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; DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively.; Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.; 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.
Other intervention name(s): Coarsucam by Sanofi-Aventis; Artekin, Eurartekin by Sigma Tau; NOTE: batches expire on 31Oct08. Due to unavailability of new batches, recruitment in this arm was discontinued on 30Oct08.; Coartem, Riamet by Novartis; Lapdap by GSK.; Arsumax by Sanofi and Guilin.
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Amodiaquine; Artenimol; Dapsone; Chlorproguanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children 6-59 months; P.falciparum; Haemoglobin; Informed consent; ACT