Prevention of Severe Anaemia in Gambian Children
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Purpose
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 |
|---|---|---|
|
Anemia |
Drug: sulfadoxine-pyrimethamine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Chemoprophylaxis With Sulfadoxine-Pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years |
- Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl [ Time Frame: at end of the malaria transmission season ]
- haemoglobin concentration [ Time Frame: At the end of malaria transmission season ]
- heamoglobin conectration [ Time Frame: at the end of malaria transmission season ]
- Proportion of children with anaemia (Hb <11g/dl) and those with severe anaemia (Hb <5 g/dl) [ Time Frame: at end of the malaria transmission season ]
- Mean Hb : Difference between S/P and placebo, Difference between S/P and placebo adjusted for baseline Hb and other covariates [ Time Frame: at the end of the malaria transmission season ]
- Number of outpatient department (OPD) attendances with malaria [ Time Frame: during the surveillance period ]
- Number of hospital admissions with malaria [ Time Frame: during the surveillance period ]
- Number of episodes of severe malaria [ Time Frame: during the surveillance period ]
- Deaths (all-cause and malaria-specific) [ Time Frame: during the surveillance period ]
- Adherence to the study regimen: The number of doses of medication received by children in each group as a proportion of the total number of doses that should have been received [ Time Frame: during the study period ]
- OPD attendance with malaria [ Time Frame: during the surveillance period ]
| Enrollment: | 1200 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | May 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 3 Months to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 3 months to 9 years.
- Haemoglobin concentration 7g/dl on admission to hospital.
- Residence within 30 km of the study centre and availability for the duration of the study period.
- Informed consent to participate in the study given by the parent or guardian.
Exclusion Criteria:
- Simultaneous participation in any other trial.
- Allergy to sulpha drugs.
- Residence > 30 km from the recruitment site.
- Lack of consent.
Contacts and Locations| Gambia | |
| Medical Research Council Laboratories, | |
| Banjul, Gambia | |
| Study Chair: | Brian Greenwood, MD | London School of Hygiene and Tropical Medicine |
More Information
No publications provided by Gates Malaria Partnership
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00131716 History of Changes |
| Other Study ID Numbers: | ITCRVG33. |
| Study First Received: | August 18, 2005 |
| Last Updated: | February 7, 2008 |
| Health Authority: | Gambia: MRC Ethics Committee |
Keywords provided by Gates Malaria Partnership:
|
prevention recurrence severe anaemia |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases Pyrimethamine Sulfadoxine Sulfadoxine-pyrimethamine Antimalarials Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on May 21, 2013