This is a phase-three malaria drug trial that has just taken off in Kintampo. The purpose of this study is to investigate if a new drug called CDA (Lapdap-artesunate) is as safe and effective to artemether-lumifantrine in the treatment of uncomplicated P. falciparum malaria.

LAPDAP (chlorproguanil-dapsone) has been approved for the treatment of uncomplicated Plasmodium falciparum malaria across a number of sub-Saharan Africa. The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supercede LAPDAP for the same indication, but the addition of an artemisinin derivative, artesunate, is expected to provide additional population benefits over LAPDAP alone.

Artemether-lumefantrine (Coartem) 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. If successful, CDA is expected to come out as another fixed dose combination therapy for the treatment of P. falciparum.

Study Design

The study is a multi- centre, parallel group, double-blind, double-dummy, randomized controlled trial of CDA verses artemether-lumefantrine. A total of one thousand, three hundred and ninety-five (1395) children and adolescents within the ages of one year to fourteen years who have uncomplicated malaria are expected to be enrolled in the study from five sites in four African Countries. The Kintampo site is however expected to recruit one hundred (100) subjects in the study.

Subjects are screened and randomized on the first day of enrolment. A subject who qualifies to be enrolled into the study is randomized to receive CDA or artemether-lumifantrine in the ratio of 2:1 respectively. Those who enroll into the study are observed for three days (from day 0 to day 3). During this period of observation, subjects are dosed with CDA or placebo once daily for three successive days whilst the dose for coartem or placebo is twice daily during the same three day period (days 0, 1 and 2). They are then followed up on days 7, 14, 28 and 42 with reference to day treatment started and also on any additional day on request or whenever the subject is taken ill.

The randomization schedule is generated automatically by a Registration And Randomization Ordering System (RAMOS). This system which operates from a central base by GSK involves providing information on an eligible subject at a time to get him/her registered. It is only after registering a subject that s/he is randomized for treatment and assigned study drug container numbers. It is after these processes that the study drug can be administered to a study subject. The entire RAMOS process on site is facilitated by a mobile phone communication system.

Sponsors: GlaxoSmithKline (GSK), Medicines for Malaria Venture (MMV), World Health Organization (WHO-TDR) and Ghana Health Service (GHS)

Contact: Livesy Abokyi

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