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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Ministry of Health and Population, Malawi |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00164359 |
Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to an imminent need for the government of Malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new therapy as policy. This protocol is the second of two protocols whose combined purpose is to provide efficacy and side effect data on four antimalarial drug combinations that are candidates for the next first-line therapy for uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry in 1995 because of a perceived association with abdominal pain. Although no studies were conducted to substantiate this, consensus among clinicians was that patients were refusing amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was removed from the registry. Results from this study, along with the efficacy data from the sister protocol in children under five years of age, will help guide the National Malaria Control Program of Malawi in selecting their next first-line antimalarial therapy.
Condition | Intervention | Phase |
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Malaria, Falciparum |
Drug: Amodiaquine plus artesunate Drug: chlorproguanil-dapsone plus artesunate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Randomised Trial to Assess the Tolerability of Amodiaquine Plus Artesunate (AQ-Art) Versus Chlorproguanil Plus Dapsone Plus Artesunate (CDA) in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi |
Estimated Enrollment: | 212 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | September 2005 |
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Malawi, Lilongwe District | |
Kawale Health Center | |
Lilongwe, Lilongwe District, Malawi | |
Malawi, Machinga District | |
Machinga District Hospital | |
Liwonde, Machinga District, Malawi | |
Malawi, Nkhotakota District | |
Matiki Health Center | |
Dwangwa, Nkhotakota District, Malawi |
Principal Investigator: | Rachel N Bronzan, MD, MPH | Centers for Disease Control and Prevention |
Study ID Numbers: | CDC-NCID-4538, PA#04018 |
Study First Received: | September 9, 2005 |
Last Updated: | September 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00164359 |
Health Authority: | United States: Federal Government |
malaria, falciparum antimalarials |
Folic Acid Artesunate Protozoan Infections Amodiaquine Dapsone |
Parasitic Diseases Malaria Chlorproguanil Malaria, Falciparum |
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 |