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

October 14, 2024 updated by: Simon Grandjean Lapierre, Institut Pasteur de Madagascar

Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - a Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Madagascar
      • Vohibato, Madagascar
        • Fokontany Vohibato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects suspected TB
  • subject living in the study area

Exclusion Criteria:

  • unable to take a sputum sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Madagascar standard of care

Description :

  • Passive case finding,
  • Smear microscopy testing, and
  • household contact tracing
No Intervention: Best practices

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
Experimental: Novel intervention

Description :

  • Active case finding,
  • Smear microscopy
  • Xpert MTB/RIF Ultra testing and
  • household contact tracing
Other: Whole Genome Sequencing testing
Whole Genome Sequencing testing, community-based contact tracing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the total number of TB cases detected / 100 000 inhabitants
Time Frame: 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.
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur de Madagascar

Collaborators

Centre de Recherche du Centre Hospitalier de l'Université de Montréal
The National Tuberculosis Program, Madagascar

Investigators

  • Principal Investigator: Simon Grandjean Lapierre, MD MSc FRCPC, CHUM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01
  • PJT 75243 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request to the investigator

IPD Sharing Time Frame

Upon request

IPD Sharing Access Criteria

Upon request to the investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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