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

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.

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 )

Overall Status Completed
Start Date October 2006
Completion Date February 2007
Primary Completion Date February 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Malaria episodes 4 weeks
Secondary Outcome
Measure Time Frame
Malaria related admissions 1 month
Adverse drug effects 4 weeks
Enrollment 220
Condition
Intervention

Intervention Type: Drug

Intervention Name: sulfadoxine pyrimethamine

Description: Monthly SP

Arm Group Label: Sulfadoxine-pyrimethamine

Other Name: SP

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

Overall Official
Location
Facility: Mulago Hospital
Location Countries

Uganda

Verification Date

July 2009

Responsible Party

Name Title: James K Tumwine

Organization: Department of Paediatrics and Child Health Makerere University

Keywords
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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov