Pharmacovigilance for ACTs in Africa (PVACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Tinto Halidou, Centre Muraz
ClinicalTrials.gov Identifier:
NCT01232530
First received: November 1, 2010
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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.


Condition
Malaria

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacovigilance for Artemisinin-based Combination Treatments in Africa

Resource links provided by NLM:


Further study details as provided by Centre Muraz:

Biospecimen Retention:   Samples With DNA

Blood spot on filter paper for PCR analysis


Estimated Enrollment: 9600
Study Start Date: June 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232530

Locations
Burkina Faso
Clinical Research Unit of Nanoro (CRUN) / Centre Muraz
Nanoro, Boulkiemdé, Burkina Faso, 211
Sponsors and Collaborators
Centre Muraz
World Health Organization
Investigators
Principal Investigator: Halidou Tinto, PharmD, PhD Centre Muraz
  More Information

No publications provided

Responsible Party: Tinto Halidou, Theme leader of the Drug Resistance and alternative therapeutics, Centre Muraz
ClinicalTrials.gov Identifier: NCT01232530     History of Changes
Other Study ID Numbers: WHO/TDR - A70283
Study First Received: November 1, 2010
Last Updated: September 29, 2012
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Centre Muraz:
Malria, ACT, Safety, Efficacy, pregarnancy

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 18, 2014