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Sponsors and Collaborators: |
Gates Malaria Partnership HealthNet International |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00158587 |
Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school.
Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
Condition | Intervention | Phase |
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Malaria Vivax Malaria |
Drug: primaquine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Placebo Controlled, Randomised Evaluation of an Eight Week Primaquine Regimen for the Treatment of Vivax Malaria. |
Enrollment: | 150 |
Study Start Date: | April 2004 |
Study Completion Date: | March 2007 |
Ages Eligible for Study: | 3 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | DIF23 |
Study First Received: | September 9, 2005 |
Last Updated: | July 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00158587 |
Health Authority: | Pakistan: Ministry of Health; Pakistan: Research Ethics Committee |
Vivax Treatment Primaquine Asia |
Protozoan Infections Primaquine Malaria, Vivax Parasitic Diseases Malaria |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Pharmacologic Actions |