Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium
falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's
Medicines and Healthcare products Regulatory Agency.
CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a
public-private partnership with the Medicines for Malaria Venture (MMV), World Health
Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical
Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a
treatment for acute uncomplicated P. falciparum malaria.
The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede
chlorproguanil-dapsone for the same indication, but the addition of an artemisinin
derivative, artesunate, should provide additional population benefits over
chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce
parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The
addition of a second agent to the chlorproguanil-dapsone combination should also protect
against the selection of resistant strains of P.falciparum.
Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination
Therapy actually available and is considered as the gold standard for the treatment of P.
falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the
combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key
secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance
Times (FCT) between CDA and artemether-lumefantrine.