NCT01232530

Pharmacovigilance for ACTs in Africa

Pharmacovigilance for Artemisinin-based Combination Treatments in Africa

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,176 (actual)
• Sponsor: Centre Muraz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 and passive) based on a repeat survey of the study population. The active surveillance population will be weekly and actively visited at home at day 7, day 14 and day 28 after drug administration. The passive surveillance population will be encouraged to report passively any AE/ADR and they will NOT be actively visited at home. In addition, the possible exposure to ACTs of all the pregnant women identified during the repeat surveys in both the active and passive surveillance areas will be extracted from the drug exposure log book or elicited by history, and the data will be entered into a pregnancy register. For the effectiveness study, patients with a microscopically confirmed diagnosis of malaria (any parasite density), clinical symptoms and a blood sample for thick and thin blood smears, and later PCR analysis (on filter paper) for genotyping will be collected before antimalarial treatment, at day 28 after treatment and at any unscheduled visit. This will be repeated for each confirmed malaria episode.

Conditions

• Malaria

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2010-11-02
• Last updated: 2015-07-31

Locations

1 site across 1 country: Burkina Faso