Overview

Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
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 anemia, and the overall morbidity and mortality
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bernhard Nocht Institute for Tropical Medicine
Collaborators:
Deutscher Akademischer Austausch Dienst
German Federal Ministry of Education and Research
The Volkswagen Foundation
Treatments:
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
Criteria
Inclusion Criteria:

- Informed consent by parent/guardian (written or oral)

- Permanent residentship in the study area

- Age of 3 months +/-4 weeks

Exclusion Criteria:

- 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