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Intermittent Antimalaria Treatment With SP in African Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2003 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168948
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deutscher Akademischer Austausch Dienst
Information provided by:
Charite University, Berlin, Germany
  Purpose
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168948


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00168948     History of Changes
Other Study ID Numbers: 01KA0202-T
01KA0202
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
Last Verified: February 2003

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

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action