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NCT05406453 Clinical Trial

Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar

Tuberculosis Clinical Trial

— TB_WGS_cRCT  

Official title:
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - A Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05406453
Other study ID # 2022-01
Secondary ID PJT 75243
Status Recruiting
Phase N/A
First received
Last updated
Start date May 16, 2022
Est. completion date September 1, 2025

Study information
Verified date September 2023
Source Institut Pasteur de Madagascar
Contact Simon Grandjean Lapierre, MD MSc FRCPC
Phone 514 890 8000
Email simon.grandjean.lapierre@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 86400
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Subjects suspected TB - subject living in the study area Exclusion Criteria: - unable to take a sputum sample

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Whole Genome Sequencing testing
Whole Genome Sequencing testing, community-based contact tracing

Locations
Country Name City State
Madagascar Fokontany Vohibato Vohibato

Sponsors (3)
Lead Sponsor Collaborator
Institut Pasteur de Madagascar Centre de Recherche du Centre Hospitalier de l'Université de Montréal, The National Tuberculosis Program, Madagascar

Country where clinical trial is conducted

Madagascar, 

Outcome
Type Measure Description Time frame Safety issue
Primary the total number of TB cases detected / 100 000 inhabitants total number of TB cases detected / 100,000 inhabitants / year in each group during the first year of the intervention. an average of 1 year
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