Pharmacovigilance for ACTs in Africa (PVACT)

Muraz Center

Status: Completed

Conditions: Malaria

Study type: Observational

Funder types: Other

Identifiers

NCT01232530

WHO/TDR - A70283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,176 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

3,176 participants in 4 patient groups

Safety Active Surveillance Group

Description:

For the active surveillance, all age groups, including children less than 5 years of age, will be identified from the census database and encouraged to attend the health facility whenever sick. Those with a diagnosis of malaria and treated with an antimalarial drug will be actively monitored for AEs.

Safety Passive Surveillance Group

Description:

For the people under passive surveillance, sick subjects attending the health facilities, diagnosed with malaria and treated with an antimalarial drug will be identified from the census database. The treatment administered will be recorded in a drug exposure log book and the patients will be encouraged to report passively any AE/ADR.

Early Pregnancy Exposure to ACTs Group

Description:

All the pregnant women identified during the repeat surveys will be included in a pregnancy cohort. At the time the pregnant woman is identified, her possible exposure to ACTs will be extracted from the drug exposure log book or elicited by history. Births identified through the repeat surveys or any other outcome of pregnancy will be retrospectively matched with antimalarial treatment exposure, particularly during the first trimester of the pregnancy.

ACT Effectiveness Monitoring Group

Description:

Besides monitoring AEs and ADRs, data on the effectiveness of ACTs when used in "real life" conditions and on a large scale will be collected in the active surveillance area. For patients with a microscopically confirmed diagnosis of malaria, clinical symptoms and a blood sample for thick and thin blood smears, will be collected before antimalarial treatment, at day 28 after treatment and at any unscheduled visit. Treatment administration will not be supervised.