Mulago Hospital
Kampala, Central Region, 256, Uganda
NCT Number: NCT00399074
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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Notify Me6 month–12 year
All sexes
Interventional
Phase 3
Kampala, Central Region, 256, Uganda
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 )
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Monthly SP
Other names: SP
Time frame: 4 weeks
Time frame: 1 month
Time frame: 4 weeks
Makerere University
Other
Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia
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