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Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia

Primary Purpose

Sickle Cell Anemia, Malaria

Status

Completed

Phase

Phase 3

Locations

Uganda

Study Type

Interventional

Intervention

sulfadoxine pyrimethamine

About this trial

This is an interventional prevention trial for Sickle Cell Anemia focused on measuring Sickle Cell anemia, Malaria, Presumptive treatment, Sulfadoxine- pyrimethamine, Children, Uganda

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mulago Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Arm Label

chloroquine

Sulfadoxine-pyrimethamine

Arm Description

Weekly CQ

Monthly SP

Outcomes

Primary Outcome Measures

Malaria episodes

Secondary Outcome Measures

Malaria related admissions

Adverse drug effects

Full Information

NCT ID

NCT00399074

First Posted

November 13, 2006

Last Updated

July 1, 2009

Sponsor

Makerere University

1. Study Identification

Unique Protocol Identification Number

NCT00399074

Brief Title

Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Makerere University

4. Oversight

5. Study Description

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 )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Anemia, Malaria

Keywords

Sickle Cell anemia, Malaria, Presumptive treatment, Sulfadoxine- pyrimethamine, Children, Uganda

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chloroquine

Arm Type

No Intervention

Arm Description

Weekly CQ

Arm Title

Sulfadoxine-pyrimethamine

Arm Type

No Intervention

Arm Description

Monthly SP

Intervention Type

Drug

Intervention Name(s)

sulfadoxine pyrimethamine

Other Intervention Name(s)

Intervention Description

Monthly SP

Primary Outcome Measure Information:

Title

Malaria episodes

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Malaria related admissions

Time Frame

1 month

Title

Adverse drug effects

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Overall Study Officials: