NCT05406453Completed
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - a Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.
Source: ClinicalTrials.gov · Last updated 16 Oct 2024
Brief summary (registry, in English)
Tuberculosis (TB) whole genome sequencing (WGS) allows outbreak identification and disease transmission tracking. It is hypothesized that prospective WGS-guided epidemiological investigations improve case detection compared to current best practices by adapting contact tracing strategies to local transmission patterns. A cluster randomized controlled trial (cRCT) will be performed in high TB incidence villages of Haute Matsiatra region in Madagascar. Communities will be randomized in three separate TB control strategies comparing (1) standard of care, (2) the World Health Organization (WHO) recommended best practices and (3) a novel intervention involving TB WGS cluster-guided epidemiological investigations. The incremental value of TB WGS on case notifications and reduction of TB burden will be measured. Secondary studies will be nested within this cRCT will include: * A qualitative study which will increase the understanding of the factors facilitating and hindering implementation of WGS-based diagnostics within health systems. * A cost effectiveness analysis study which will measure the cost effectiveness of newly implemented laboratory methods. Field and genomic epidemiology data from this project will inform future work on the design of community-level TB elimination strategies in collaboration with Madagascar National TB program
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 98362 (actual)
- First submitted
- 2 Jun 2022
- Start date
- 16 May 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Institut Pasteur de Madagascar
- Diseases
- Tuberculosis
- NCT number
- NCT05406453
What you commit to
- Study type: Interventional
- Participants enrolled: 98362
- From 16 May 2022 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- unable to take a sputum sample
Who the study is looking for
- Subjects suspected TB
- subject living in the study area
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fokontany Vohibato Coordinator of this site? Confirm its status | Vohibato | Madagascar | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.