Pharmacovigilance for ACTs in Africa (PVACT)

July 29, 2015 updated by: Tinto Halidou, Centre Muraz

Pharmacovigilance for Artemisinin-based Combination Treatments in Africa

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

3176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
    • Boulkiemdé
      • Nanoro, Boulkiemdé, Burkina Faso, 211
        • Clinical Research Unit of Nanoro (CRUN) / Centre Muraz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Initially, a census of the population living in Nanoro department and around (approximately 50,000 people) will be carried out. The complete census database will be utilized to estimate the incidence of malaria episodes and to determine whether there is any clustering of malaria episodes as well as AEs. Such census will be updated by a team of 8 field workers who will visit each single household every 4 months, for at least 3 years to identify newly pregnant women and to collect information on vital events such as births and deaths. Of the 50,000 people in the census database, approximately 25,000 will be under active surveillance while the other 25,000 will be under passive surveillance.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Safety Active Surveillance Group
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
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
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Muraz

Collaborators

World Health Organization

Investigators

  • Principal Investigator: Halidou Tinto, PharmD, PhD, Centre Muraz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (ESTIMATE)

November 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHO/TDR - A70283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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