Intermittent Antimalaria Treatment With SP in African Children

Phase 4

• Conditions: Malaria; Anemia

• Registration Number: NCT00168948
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana

Detailed Description

* Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.

* It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease

* It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced

* Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined

Study Timeline

• Status Verified: 2003-02
• Study Start: 2003-03
• Study Completion: 2005-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Last Update Submitted: 2005-11-01
• Last Update Posted: 2005-11-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• informed consent by parents or guardian
• no concomitant serious disease
• age >2 months

Exclusion Criteria

• serious allergy or hypersensitivity to sulfonamides or pyrimethamine
• no severe hepatic or renal dysfunction
• serious breach of study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy and safety of IPTi with SP
Impact of IPTi on incidence on malaria attacks
Impact of IPTi on anemia

Secondary Outcome Measures

Name	Time	Method
Interaction between erythrocyte polymorphisms and SP
Influence on parasite multiplicity
Impact on child development