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Sponsors and Collaborators: |
Gates Malaria Partnership Department of State for Health and Social Welfare, The Gambia London School of Hygiene and Tropical Medicine |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00131716 |
Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.
Condition | Intervention | Phase |
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Anemia |
Drug: sulfadoxine-pyrimethamine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Chemoprophylaxis With Sulfadoxine-Pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years |
Enrollment: | 1200 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | May 2005 |
Ages Eligible for Study: | 3 Months to 9 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Gambia | |
Medical Research Council Laboratories, | |
Banjul, Gambia |
Study Chair: | Brian Greenwood, MD | London School of Hygiene and Tropical Medicine |
Study ID Numbers: | ITCRVG33. |
Study First Received: | August 18, 2005 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00131716 |
Health Authority: | Gambia: MRC Ethics Committee |
prevention recurrence severe anaemia |
Folic Acid Pyrimethamine Sulfadoxine-pyrimethamine Hematologic Diseases |
Anemia Sulfadoxine Recurrence |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Folic Acid Antagonists Pharmacologic Actions |