Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar (TB_WGS_cRCT)
Primary Purpose
Tuberculosis
Status
Recruiting
Phase
Not Applicable
Locations
Madagascar
Study Type
Interventional
Intervention
Whole Genome Sequencing testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring Whole genome sequencing, cluster randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Subjects suspected TB
- subject living in the study area
Exclusion Criteria:
- unable to take a sputum sample
Sites / Locations
- Fokontany VohibatoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Experimental
Arm Label
Madagascar standard of care
Best practices
Novel intervention
Arm Description
Description : Passive case finding, Smear microscopy testing, and household contact tracing
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
Description : Active case finding, Smear microscopy Xpert MTB/RIF Ultra testing and household contact tracing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05406453
First Posted
June 2, 2022
Last Updated
September 28, 2023
Sponsor
Institut Pasteur de Madagascar
Collaborators
The National Tuberculosis Program, Madagascar, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT05406453
Brief Title
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar
Acronym
TB_WGS_cRCT
Official Title
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - A Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Pasteur de Madagascar
Collaborators
The National Tuberculosis Program, Madagascar, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Whole genome sequencing, cluster randomized controlled trial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
cRCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Madagascar standard of care
Arm Type
No Intervention
Arm Description
Description :
Passive case finding,
Smear microscopy testing, and
household contact tracing
Arm Title
Best practices
Arm Type
No Intervention
Arm 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
Arm Title
Novel intervention
Arm Type
Experimental
Arm Description
Description :
Active case finding,
Smear microscopy
Xpert MTB/RIF Ultra testing and
household contact tracing
Intervention Type
Other
Intervention Name(s)
Whole Genome Sequencing testing
Intervention Description
Whole Genome Sequencing testing, community-based contact tracing
Primary Outcome Measure Information:
Title
the total number of TB cases detected / 100 000 inhabitants
Description
total number of TB cases detected / 100,000 inhabitants / year in each group during the first year of the intervention.
Time Frame
an average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects suspected TB
subject living in the study area
Exclusion Criteria:
unable to take a sputum sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Grandjean Lapierre, MD MSc FRCPC
Phone
514 890 8000
Ext
+1
Email
simon.grandjean.lapierre@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Niaina Rakotosamimanana, PhD
Phone
20 22 412 72
Ext
+261
Email
niaina@pasteur.mg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Grandjean Lapierre, MD MSc FRCPC
Organizational Affiliation
CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fokontany Vohibato
City
Vohibato
Country
Madagascar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nöela Christine ANDRIAMANOHA, MD
Email
achristine@pasteur.mg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request to the investigator
IPD Sharing Time Frame
Upon request
IPD Sharing Access Criteria
Upon request to the investigator
Learn more about this trial
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar
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