Status:
COMPLETED
Pharmacovigilance for ACTs in Africa
Lead Sponsor:
Centre Muraz
Collaborating Sponsors:
World Health Organization
Conditions:
Malaria
Eligibility:
All Genders
Brief Summary
This is a phase IV open label study assessing the safety and effectiveness of artemisinin derivatives-based combination therapy (ACT) when used on a large scale and under "real life" conditions.
Detailed Description
The study will be conducted in a well defined population in Burkina Faso by setting up a population-based monitoring system. The monitoring for adverse events (AEs) will use two approaches (active an...
Eligibility Criteria
Inclusion
- Males and Females living in Nanoro DSS catchment area;
- Signed (or thumb-printed whenever patients are illiterate) informed consent.
- Patients' willingness and ability to comply with the study protocol for the duration of the study.
Exclusion
- Severe malaria.
- Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
3176 Patients enrolled
Trial Details
Trial ID
NCT01232530
Start Date
June 1 2010
End Date
December 1 2013
Last Update
July 31 2015
Active Locations (1)
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1
Clinical Research Unit of Nanoro (CRUN) / Centre Muraz
Nanoro, Boulkiemdé, Burkina Faso, 211