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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00371735 |
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.
Condition | Intervention | Phase |
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Malaria |
Drug: chlorproguanil-dapsone-artesunate Drug: chlorproguanil-dapsone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 900 |
Study Start Date: | April 2006 |
Ages Eligible for Study: | 12 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Burkina Faso | |
GSK Investigational Site | |
Ouagadougou, Burkina Faso | |
Ghana | |
GSK Investigational Site | |
Kumasi, Ghana | |
Mali | |
GSK Investigational Site | |
Bamako, Mali | |
Nigeria | |
GSK Investigational Site | |
Ile-Ife, Nigeria | |
GSK Investigational Site | |
Lagos, Nigeria | |
GSK Investigational Site | |
Jos, Nigeria |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CDA 714703/006 |
Study First Received: | September 1, 2006 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00371735 |
Health Authority: | Nigeria: National Agency for Food and Drug Administration and Control Ghana: Food and Drugs Board (FDB) Mali: Direction de la Pharmacie et du Medicament (DPM) |
Malaria
CDA
LAPDAP
Africa |
Folic Acid Artesunate Protozoan Infections Chloroguanide Dapsone |
Parasitic Diseases Malaria Chlorproguanil Malaria, Falciparum |
Antimetabolites Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Antimalarials Anti-Bacterial Agents Antiparasitic Agents Therapeutic Uses Amebicides Leprostatic Agents |