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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
September 13, 2005
September 15, 2005
December 9, 2005
March 2003
Not Provided
  • Efficacy and safety of IPTi with SP
  • Impact of IPTi on incidence on malaria attacks
  • Impact of IPTi on anemia
Same as current
Complete list of historical versions of study NCT00168948 on ClinicalTrials.gov Archive Site
  • Interaction between erythrocyte polymorphisms and SP
  • Influence on parasite multiplicity
  • Impact on child development
Same as current
Not Provided
Not Provided
 
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
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana
  • 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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Malaria
  • Anemia
Drug: Sulfadoxin (12.5) Pyrimethamine (250 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1200
August 2005
Not Provided

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
Sexes Eligible for Study: All
2 Months to 4 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00168948
01KA0202-T
01KA0202
Not Provided
Not Provided
Not Provided
Not Provided
Charite University, Berlin, Germany
Deutscher Akademischer Austausch Dienst
Study Director: Frank Mockenhaupt, PhD Charite University-Medicine, Berlin, Germany
Charite University, Berlin, Germany
February 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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