This trial is active, not recruiting.

Conditions malaria, anemia
Treatment sulfadoxin (12.5) pyrimethamine (250 mg)
Phase phase 4
Sponsor Charite University, Berlin, Germany
Collaborator Deutscher Akademischer Austausch Dienst
Start date March 2003
End date August 2005
Trial size 1200 participants
Trial identifier NCT00168948, 01KA0202, 01KA0202-T


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Efficacy and safety of IPTi with SP
time frame:
Impact of IPTi on incidence on malaria attacks
time frame:
Impact of IPTi on anemia
time frame:

Secondary Outcomes

Interaction between erythrocyte polymorphisms and SP
time frame:
Influence on parasite multiplicity
time frame:
Impact on child development
time frame:

Eligibility Criteria

Male or female participants from 2 months up to 4 months old.

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

Additional Information

Official title Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2005.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.