TuberculosisTB_WGS_cRCTNCT05406453
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar
A study testing Whole Genome Sequencing testing in people with Tuberculosis, run by Institut Pasteur de Madagascar at 1 site in Madagascar.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Whole Genome Sequencing testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98,362 participants
- Where
- 1 siteMadagascar
- Study dates
- 16 May 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects suspected TB
- subject living in the study area
Who cannot join
- unable to take a sputum sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Conditions
- Tuberculosis
- Being tested
- Whole Genome Sequencing testing
- Keywords
- Whole genome sequencing, cluster randomized controlled trial
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Genome Sequencing testingOther
Whole Genome Sequencing testing, community-based contact tracing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Whole Genome Sequencing testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start16 May 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- cRCT
- Masking
- None (open label)
- Enrolment
- 98,362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Madagascar
- Sponsor type
- University, hospital or other
- Collaborators
- The National Tuberculosis Program, Madagascar, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Principal investigator, Simon Grandjean Lapierre, Institut Pasteur de Madagascar
- Investigators
- Simon Grandjean Lapierre, MD MSc FRCPC, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406453
- Sponsor's protocol ID
- 2022-01
- Other IDs
- PJT 75243
- Acronym
- TB_WGS_cRCT
- Status last verified
- Oct 2024
- First submitted
- 2 Jun 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request to the investigator
Publications
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.
PubMed 39456079
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - a Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.
- ClinicalTrials.gov ID
- NCT05406453
- Acronym / sponsor ID
- TB_WGS_cRCT / 2022-01
- Conditions
- Tuberculosis
- Keywords
- Whole genome sequencing, cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98,362 participants (actual)
- Lead sponsor
- Institut Pasteur de MadagascarUniversity, hospital or other
- Collaborators
- The National Tuberculosis Program, Madagascar, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- cRCT
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Whole Genome Sequencing testingDescription : * Active case finding, * Smear microscopy * Xpert MTB/RIF Ultra testing and * household contact tracing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects suspected TB
- subject living in the study area
Key exclusion criteria (1 listed)
- unable to take a sputum sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Genome Sequencing testingWhole Genome Sequencing testing, community-based contact tracing | Other | Novel intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 39456079Ametepe 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.
- Individual participant dataSharing planned: Yes. Upon request to the investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Grandjean Lapierre, MD MSc FRCPC principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Genome Sequencing testing in people with Tuberculosis, run by Institut Pasteur de Madagascar at 1 site in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total number of TB cases detected / 100 000 inhabitants (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.