Beschrijving

General
To compare the safety and efficacy of 4 artemisinin-based combination therapies (ACT), i.e. amodiaquine-artesunate (AQ+AS), artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHAPQ), chlorproguanil-dapsone plus artesunate (CD-A), for single and repeat treatments of uncomplicated malaria in African 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.


Specific


To evaluate the efficacy of the 4 ACTs for the treatment of children with uncomplicated P. falciparum malaria (first active follow-up)To determine after the first active follow-up the incidence rate of a second clinical episode of uncomplicated P. falciparum malariaTo evaluate the efficacy of treating the second clinical episode of uncomplicated P. falciparum malaria with the same ACT used for the first one (second active follow-up)To evaluate during the active and passive follow up the safety of the 4 ACTs for the treatment of children with uncomplicated P. falciparum malariaTo establish the impact of using CD-A on the selection of P. falciparum genotypes linked to SP resistance.
Acroniem4 ABC
StatusVoltooid
Effectieve start/einddatum12/12/0530/06/10

Financiering

  • European & Developing Countries Clinical Trials Partnership : 864.234,00 €

ID: 1078202