Malaria Clinical Trial
Official title:
Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia
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.
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 )
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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