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Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar

NCT05406453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98362

Last updated 2024-10-16

No results posted yet for this study

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

Conditions

Interventions

OTHER

Whole Genome Sequencing testing

Whole Genome Sequencing testing, community-based contact tracing

Sponsors & Collaborators

  • The National Tuberculosis Program, Madagascar

    collaborator UNKNOWN

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    collaborator OTHER

  • Institut Pasteur de Madagascar

    lead OTHER

Principal Investigators

  • Simon Grandjean Lapierre, MD MSc FRCPC · CHUM

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Madagascar

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406453 on ClinicalTrials.gov