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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05406453
Acronym
TB_WGS_cRCT
Enrollment
98362
Registered
2022-06-06
Start date
2022-05-16
Completion date
2024-06-30
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Whole genome sequencing, cluster randomized controlled trial

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

Interventions

Whole Genome Sequencing testing, community-based contact tracing

Sponsors

The National Tuberculosis Program, Madagascar
CollaboratorUNKNOWN
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
CollaboratorOTHER
Institut Pasteur de Madagascar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

cRCT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Subjects suspected TB * subject living in the study area

Exclusion criteria

* unable to take a sputum sample

Design outcomes

Primary

MeasureTime frameDescription
the total number of TB cases detected / 100 000 inhabitantsan average of 1 yeartotal number of TB cases detected / 100,000 inhabitants / year in each group during the first year of the intervention.

Countries

Madagascar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026