- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406453
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar (TB_WGS_cRCT)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simon Grandjean Lapierre, MD MSc FRCPC
- Phone Number: +1 514 890 8000
- Email: simon.grandjean.lapierre@umontreal.ca
Study Contact Backup
- Name: Niaina Rakotosamimanana, PhD
- Phone Number: +261 20 22 412 72
- Email: niaina@pasteur.mg
Study Locations
-
-
-
Vohibato, Madagascar
- Recruiting
- Fokontany Vohibato
-
Contact:
- Nöela Christine ANDRIAMANOHA, MD
- Email: achristine@pasteur.mg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects suspected TB
- subject living in the study area
Exclusion Criteria:
- unable to take a sputum sample
Study Plan
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 :
|
|
No Intervention: Best practices
Description :
|
|
Experimental: Novel intervention
Description :
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Simon Grandjean Lapierre, MD MSc FRCPC, CHUM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tuberculosis
-
Global Alliance for TB Drug DevelopmentCompletedTuberculosis | Tuberculosis, Pulmonary | Pulmonary Disease | Multi Drug Resistant Tuberculosis | Drug Sensitive Tuberculosis | Drug-resistant Tuberculosis | Mycobacterium Tuberculosis InfectionUnited States
-
Global Alliance for TB Drug DevelopmentCompletedTuberculosis | Tuberculosis, Pulmonary | Pulmonary Disease | Multi Drug Resistant Tuberculosis | Drug Sensitive Tuberculosis | Drug-resistant Tuberculosis | Mycobacterium Tuberculosis InfectionUnited States
-
University of Cape TownUniversity of Stellenbosch; University of Cape Town Lung Institute; University... and other collaboratorsCompletedTuberculosis | Multidrug Resistant Tuberculosis | Extensively-drug Resistant TuberculosisSouth Africa
-
Universiteit AntwerpenAurum Institute; University of Stellenbosch; University of the Free State; Free...RecruitingDrug-resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses | Multidrug Resistant TuberculosisSouth Africa
-
University Medical Center GroningenCompletedMultidrug-resistant Tuberculosis | Extensively Drug-resistant TuberculosisNetherlands
-
Assistance Publique - Hôpitaux de ParisCompletedExtrapulmonary Tuberculosis | Lymph Node Tuberculosis | Bone TuberculosisFrance
-
Centers for Disease Control and PreventionBoston University; Pfizer; Columbia University; University of Texas; University of... and other collaboratorsCompletedMulti-Drug Resistant Tuberculosis | Extensively Drug Resistant TuberculosisSouth Africa
-
Foundation for Innovative New Diagnostics, SwitzerlandInstitute of Tropical Medicine, Belgium; Research Center Borstel; National Institute...CompletedMultidrug-Resistant Tuberculosis | Isoniazid Resistant Pulmonary Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses
-
National Institute of Allergy and Infectious Diseases...CompletedPulmonary Tuberculosis | Multidrug Resistant Tuberculosis | Extensively Drug Resistant TuberculosisKorea, Republic of
-
Wits Health Consortium (Pty) LtdUniversity of Cape Town; Perinatal HIV Research Unit of the University of the... and other collaboratorsActive, not recruitingTuberculosis | Multi Drug Resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Extensively Drug-Resistant Tuberculosis | Pre-XDR-TBSouth Africa
Clinical Trials on Whole Genome Sequencing testing
-
University Health Network, TorontoWestern University, Canada; Public Health Ontario Laboratory, CanadaRecruitingRespiratory Tract Diseases | Mycobacterium Infections | Mycobacterium Infections, Nontuberculous | Nontuberculous Mycobacterial Lung Disease | Mycobacterium AviumCanada
-
Kaiser PermanenteNational Human Genome Research Institute (NHGRI)CompletedGenetic DisordersUnited States
-
Children's Hospital of Fudan UniversityNot yet recruitingDiarrhea, Infantile | Enteropathy
-
Thomas Jefferson UniversityRecruitingGenetic Disorders | Nonimmune Fetal Hydrops | Nonimmune Hydrops in NeonateUnited States
-
Heinrich-Heine University, DuesseldorfGerman Cancer AidNot yet recruitingProstate Cancer | Familial Prostate Cancer
-
Boston Children's HospitalNational Eye Institute (NEI)RecruitingStrabismus | Nystagmus, CongenitalUnited States
-
Institut National de la Santé Et de la Recherche...Hospices Civils de Lyon; University Hospital, Rouen; Centre Hospitalier Universitaire... and other collaboratorsActive, not recruitingIntellectual DisabilityFrance
-
Nantes University HospitalAXA Assurances VIE MutuelleNot yet recruitingSudden Infant Death | Sudden Unexplained Infant DeathFrance
-
University of CambridgeIllumina, Inc.; Rosetrees Trust; Isaac Newton Trust; NIHR Cambridge Biomedical...Recruiting
-
Istituto Superiore di SanitàFondazione G.B. Bietti, IRCCS; Ospedale Pediatrico Bambin GesùRecruitingRetinitis Pigmentosa | Macular Dystrophy | Inherited Retinal DystrophyItaly