NCT05406453

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98,362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

June 2, 2022

Last Update Submit

October 14, 2024

Conditions

Tuberculosis

Keywords

Whole genome sequencingcluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Madagascar standard of care

NO INTERVENTION

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

Best practices

NO INTERVENTION

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

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

Other: Whole Genome Sequencing testing

Interventions

Whole Genome Sequencing testingOTHER

Whole Genome Sequencing testing, community-based contact tracing

Novel intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects suspected TB
  • subject living in the study area

You may not qualify if:

  • unable to take a sputum sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fokontany Vohibato

Vohibato, Madagascar

Location

Related Publications (1)

  • Ametepe ESA, Andriamanoha N, Andrianomanana FR, Point F, Mangahasimbola RT, Dyachenko A, Hall M, Gamana TM, Knoblauch AM, Razafindrasoa YY, Nimalan A, Behr M, Durand M, Johri M, Iqbal Z, Rakotoarivelo AR, Randremanana RV, Rakotosamimanana N, Lapierre SG. Whole genome sequencing of M. tuberculosis for disease control in high-burden settings: study protocol for a cluster randomized controlled trial evaluating different community-wide intervention strategies in rural Madagascar. Trials. 2024 Oct 25;25(1):717. doi: 10.1186/s13063-024-08537-4.

    PMID: 39456079DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Simon Grandjean Lapierre, MD MSc FRCPC

    CHUM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Model Details: cRCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 6, 2022

Study Start

May 16, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Upon request to the investigator

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Upon request
Access Criteria
Upon request to the investigator

Locations

MA(1)