Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia
Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia
| Sponsors |
Lead Sponsor: Makerere University |
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| Source | Makerere University | ||||||
| Brief Summary | Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia. Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia. |
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| Detailed Description | Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces incidence of malaria among high risk group such as children with sickle cell anaemia. We calculated a sample size of 110 patients in each group for a power of 95% assuming that the incidence of malaria in children receiving weekly chloroquine will be 0.36 and those receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 0.16 according to (schellenberg et al ) |
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| Overall Status | Completed | ||||||
| Start Date | October 2006 | ||||||
| Completion Date | February 2007 | ||||||
| Primary Completion Date | February 2007 | ||||||
| Phase | Phase 3 | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 220 | ||||||
| Condition | |||||||
| Intervention |
Intervention Type: Drug Intervention Name: sulfadoxine pyrimethamine Description: Monthly SP Arm Group Label: Sulfadoxine-pyrimethamine Other Name: SP |
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| Eligibility |
Criteria:
Inclusion Criteria: - Children aged 6 months to 12 years attending sickle cell clinic in Mulago Hospital during the study period with a negative peripheral smear for parasites, adherence to appointment visits, consent by care takers to participate in the study. Exclusion Criteria: - Patients with known allergy to sulfonamides, Patients with severe illnesses requiring urgent admission, Patients with documented treatment for malaria in the past one month with Sulfadoxine- Pyrimethamine. Patients on cotrimoxazole prophylaxis Gender: All Minimum Age: 6 Months Maximum Age: 12 Years Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
Uganda |
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| Verification Date |
July 2009 |
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| Responsible Party |
Name Title: James K Tumwine Organization: Department of Paediatrics and Child Health Makerere University |
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| Has Expanded Access | No | ||||||
| Condition Browse | |||||||
| Number Of Arms | 2 | ||||||
| Arm Group |
Label: chloroquine Type: No Intervention Description: Weekly CQ Label: Sulfadoxine-pyrimethamine Type: No Intervention Description: Monthly SP |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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