Malaria, Falciparum Clinical Trial
Official title:
A Multi-centre, Randomised, Double-blind Study to Compare the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Chlorproguanil-dapsone in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children, Adolescents and Adults in Africa.
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 HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has
already been shown to be efficacious against P.falciparum in adults and children in
Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase
the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any
parasites escaping treatment over the 3-day course. The addition of artesunate is also
anticipated to have the population benefit of protection against the development of
resistant strains of P.falciparum, although it will not be possible to demonstrate this in a
clinical trial. One further population benefit of the artemisinin drugs are their ability to
suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity
after antimalarial treatment and potentially lower transmission rates with widespread use,
including the spread of any parasites resistant to the partner drug.
The aims of this phase III study are to compare the efficacy of a fixed ratio combination
tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a
multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and
adults, with chlorproguanil-dapsone as a comparator.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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