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Intermittent Antimalaria Treatment With SP in African Children

Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00168948
Enrollment
1200
Registered
2005-09-15
Start date
2003-03-31
Completion date
2005-08-31
Last updated
2005-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Malaria

Keywords

Intermittent preventive treatment, IPTi, Malaria control, Ghana

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

Interventions

DRUGSulfadoxin (12.5) Pyrimethamine (250 mg)

Sponsors

Deutscher Akademischer Austausch Dienst
CollaboratorOTHER
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
2 Months to 4 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026