Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00344006 |
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.
Condition | Intervention | Phase |
---|---|---|
Malaria |
Drug: chlorproguanil-dapsone-artesunate Drug: artemether-lumefantrine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centre, Randomised, Double-Blind, Double Dummy Study Comparing the Efficacy and Safety of Chlorproguanil-Dapsone-Artesunate Versus Artemether-Lumefantrine in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children and Adolescents in Africa. |
Estimated Enrollment: | 1395 |
Study Start Date: | June 2006 |
Ages Eligible for Study: | 12 Months to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
malariae)
Burkina Faso | |
GSK Investigational Site | |
Bobo-Dioulasso, Burkina Faso | |
Ghana | |
GSK Investigational Site | |
Kintampo, Ghana | |
Kenya | |
GSK Investigational Site | |
Kilifi, Kenya | |
GSK Investigational Site | |
Eldoret, Kenya | |
Nigeria | |
GSK Investigational Site | |
Barkin Ladi, Nigeria | |
GSK Investigational Site | |
Calabar, Nigeria | |
GSK Investigational Site | |
Ibadan, Nigeria | |
Tanzania | |
GSK Investigational Site | |
Ifakara, Tanzania |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CDA 714703/005 |
Study First Received: | June 22, 2006 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00344006 History of Changes |
Health Authority: | Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC); Tazania: Tanzania Food and Drug Authority (TFDA); Kenya: Pharmacy and Poisons Board.; Ghana: Food and Drugs Board (FDB) |
Malaria
CDA
COARTEM
Africa
pediatrics
children |
Antimetabolites Artesunate Benflumetol Protozoan Infections Artemether-lumefantrine combination Anti-Infective Agents Folate Anthelmintics Malaria Folinic Acid Folic Acid Antagonists |
Vitamin B9 Malaria, Falciparum Artemether Folic Acid Anti-Bacterial Agents Antimalarials Antifungal Agents Chloroguanide Dapsone Parasitic Diseases Chlorproguanil |
Antimetabolites Benflumetol Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Malaria Artemether Antimalarials Anti-Bacterial Agents Antiparasitic Agents Antifungal Agents Therapeutic Uses Chloroguanide Dapsone Parasitic Diseases |
Amebicides Chlorproguanil Coccidiostats Artesunate Protozoan Infections Coccidiosis Antiplatyhelmintic Agents Anthelmintics Enzyme Inhibitors Folic Acid Antagonists Schistosomicides Pharmacologic Actions Malaria, Falciparum Leprostatic Agents |