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NCT Number: NCT00399074

Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention 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.

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Key information

About this study

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 )

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfadoxine pyrimethamine

Drug

Monthly SP

Other names: SP

Primary outcomes

  1. Malaria episodes

    Time frame: 4 weeks

Secondary outcomes

  1. Malaria related admissions

    Time frame: 1 month

  2. Adverse drug effects

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Official study title

Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 14, 2006
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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