Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar (TB_WGS_cRCT)

Pasteur Institute of Madagascar

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Whole Genome Sequencing testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05406453

2022-01

PJT 75243 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 98,362 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects suspected TB
• subject living in the study area

Exclusion criteria

• unable to take a sputum sample

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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98,362 participants in 3 patient groups

Madagascar standard of care

No Intervention group

Description:

Description : * Passive case finding, * Smear microscopy testing, and * household contact tracing

Best practices

No Intervention group

Description:

Description : * Active case finding, * Smear microscopy * Xpert MTB/RIF Ultra testing (= rapid test by Genexpert for tuberculosis (TB) and rifampin resistance (RIF-R)) and * household contact tracing

Novel intervention

Experimental group

Description:

Description : * Active case finding, * Smear microscopy * Xpert MTB/RIF Ultra testing and * household contact tracing

Treatment:

Other: Whole Genome Sequencing testing