Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Other: Whole Genome Sequencing testing

• Registration Number: NCT05406453
• Lead Sponsor: Institut Pasteur de Madagascar

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-16
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-06
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98362

Inclusion Criteria

• Subjects suspected TB
• subject living in the study area

Exclusion Criteria

• unable to take a sputum sample

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Novel intervention	Whole Genome Sequencing testing	Description : * Active case finding, * Smear microscopy * Xpert MTB/RIF Ultra testing and * household contact tracing

Primary Outcome Measures

Name	Time	Method
the total number of TB cases detected / 100 000 inhabitants	an average of 1 year	total number of TB cases detected / 100,000 inhabitants / year in each group during the first year of the intervention.

Trial Locations

Locations (1)

Fokontany Vohibato; 🇲🇬 Vohibato, Madagascar