Pharmacovigilance for ACTs in Africa

Completed

• Conditions: Malaria

• Registration Number: NCT01232530
• Lead Sponsor: Centre Muraz

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 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3176

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Clinical Research Unit of Nanoro (CRUN) / Centre Muraz; 🇧🇫 Nanoro, Boulkiemdé, Burkina Faso