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| Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine Medical Research Council Laboratories, Gambia |
|---|---|
| Information provided by: | London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT00289250 |
Purpose
Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.
| Condition | Intervention | Phase |
|---|---|---|
|
Asymptomatic P.Falciparum Malaria |
Drug: Sulfadoxine-pyrimethamine Drug: Sulfadoxine-pyrimethamine plus artesunate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial |
| Estimated Enrollment: | 360 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | December 2001 |
Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.
Eligibility| Ages Eligible for Study: | 6 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Gambia | |
| Medical Reseearch Council Laboratories The Gambia | |
| BANJUL, Gambia, POBOX 273 | |
| Study Director: | Margaret Pinder, PhD | Medical Research Council Laboratories, Gambia |
| Study Chair: | Paul J Milligan, PhD | London School of Hygiene and Tropical Medicine |
| Principal Investigator: | Sam K Dunyo, PhD | Medical Research Council Laboratories, Gambia |
More Information
| Study ID Numbers: | SCC867 |
| Study First Received: | February 8, 2006 |
| Last Updated: | February 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00289250 |
| Health Authority: | Gambia: Department of State for Health and Social Welfare |
|
Malaria Gametocytes Asymptomatic carriers |
|
Folic Acid Artesunate Pyrimethamine Protozoan Infections Sulfadoxine-pyrimethamine |
Parasitic Diseases Malaria Sulfadoxine Malaria, Falciparum |
|
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists |
Renal Agents Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Amebicides |
