Intermittent Antimalaria Treatment With SP in African Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2003 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Deutscher Akademischer Austausch Dienst
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: September 13, 2005
Last updated: November 1, 2005
Last verified: February 2003
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana

Condition Intervention Phase
Drug: Sulfadoxin (12.5) Pyrimethamine (250 mg)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Efficacy and safety of IPTi with SP
  • Impact of IPTi on incidence on malaria attacks
  • Impact of IPTi on anemia

Secondary Outcome Measures:
  • Interaction between erythrocyte polymorphisms and SP
  • Influence on parasite multiplicity
  • Impact on child development

Estimated Enrollment: 1200
Study Start Date: March 2003
Estimated Study Completion Date: August 2005
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

Ages Eligible for Study:   2 Months to 4 Months
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its identifier: NCT00168948

Sponsors and Collaborators
Charite University, Berlin, Germany
Deutscher Akademischer Austausch Dienst
Study Director: Frank Mockenhaupt, PhD Charite University-Medicine, Berlin, Germany
  More Information

Additional Information:
Publications: Identifier: NCT00168948     History of Changes
Other Study ID Numbers: 01KA0202-T  01KA0202 
Study First Received: September 13, 2005
Last Updated: November 1, 2005
Health Authority: Ghana: Ministry of Health

Keywords provided by Charite University, Berlin, Germany:
Intermittent preventive treatment
Malaria control

Additional relevant MeSH terms:
Parasitic Diseases
Protozoan Infections
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on April 27, 2016