Status:
COMPLETED
Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants
Lead Sponsor:
Bernhard Nocht Institute for Tropical Medicine
Collaborating Sponsors:
German Federal Ministry of Education and Research
Deutscher Akademischer Austausch Dienst
Conditions:
Malaria
Anemia
Eligibility:
All Genders
2-4 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of ane...
Detailed Description
In order to define the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine, a novel principle of malaria intervention, the following parameters are eval...
Eligibility Criteria
Inclusion
- Informed consent by parent/guardian (written or oral)
- Permanent residentship in the study area
- Age of 3 months +/-4 weeks
Exclusion
- Hypersensitivity to sulfonamides or pyrimethamine (skin rashes, evidence of hemolysis including dark urine and/or purpura, presumptive signs of bone marrow depression such as sore throat and/or mouth ulcers)
- Other severe adverse events related to pyrimethamine-sulfadoxine application
- Signs of severe hepatic or renal dysfunction not due to malaria
- Other reasons after decision of the study physician
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
1070 Patients enrolled
Trial Details
Trial ID
NCT00206739
Start Date
January 1 2003
End Date
September 1 2005
Last Update
March 30 2010
Active Locations (1)
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1
Kumasi Centre for Collaborative Research in Tropical Medicine
Kumasi, Ashanti Region, Ghana