Active TuberculosisCOMPASS-TBNCT06408129
COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)
An observational study of Active Tuberculosis and Latent Tuberculosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Tuberculosis, Latent Tuberculosis
- How many people
- 580 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2017to 9 Apr 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients screened for tuberculosis at the Montpellier University Hospital
Who may be able to join
- Major patients who received the following examinations at the Montpellier University Hospital for tuberculosis screening (clinical suspicion and/or contact with a person with active tuberculosis):
- Chest X-ray AND
- Chest CT scan AND
- Mycobacteriology examination of respiratory or tissue sample (direct/culture/GenXpert) AND
- IGRA test (Quantiferon)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.
Read the detailed description
Background : diagnostic methods to distinguish between latent TB infection (LTBI) and active TB disease remains challenging. Data are scarce concerning the positive predictive value of Current diagnostic approaches, including Interferon-Gamma Release Assay (IGRA) and chest radiography, which is often very low. Computed tomography (CT) scanning, although not recommended by the World Health Organization (WHO) for TB diagnosis, may be of high interest in our high-income low-burden countries. This study assess the performance of the combination of CT scanning and IGRA to diagnose active pulmonary TB and identifies discriminatory CT scan features indicative of active disease.
Methods : A retrospective study was conducted on 580 patients clinically suspected of TB or in contact with bacteriologically confirmed cases (index cases). Patients underwent IGRA testing, thoracic CT scans, and respiratory (or other organs) samples culture. CT scan findings were blindly analyzed, and a composite score combining significant radiological signs with IGRA results was constructed. Diagnostic performance measures, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were calculated.
- Conditions
- Active Tuberculosis, Latent Tuberculosis
- Keywords
- Active Tuberculosis, LAtent Tuberculosis infection, Interferon-Gamma Release Assay, Quantiferon, Chest CT scan, Chest X-ray
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients clinically suspected of active tuberculosis or in contact with index cases | patients had either a clinical suspicion of active tuberculosis or underwent screening due to a close contact with another patient which had a bacteriologically confirmed active tuberculosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan
Sensitivity
Measured: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan
specificity
Measured: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Secondary outcomes (2)
Positive Predictive value of the combination of IGRA and Chest CT scan
Positive Predictive value
Measured: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Negative Predictive value of the combination of IGRA and Chest CT scan
Negative Predictive value
Measured: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start31 Jan 2017
- Primary completion31 Dec 2022
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active TuberculosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémy Charriot, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408129
- Sponsor's protocol ID
- IRB-MTP_2022_04_202201086
- Acronym
- COMPASS-TB
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)
- ClinicalTrials.gov ID
- NCT06408129
- Acronym / sponsor ID
- COMPASS-TB / IRB-MTP_2022_04_202201086
- Conditions
- Active Tuberculosis, Latent Tuberculosis
- Keywords
- Active Tuberculosis, LAtent Tuberculosis infection, Interferon-Gamma Release Assay, Quantiferon, Chest CT scan, Chest X-ray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 9 May 2024 (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.
The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.
Detailed description
Background : diagnostic methods to distinguish between latent TB infection (LTBI) and active TB disease remains challenging. Data are scarce concerning the positive predictive value of Current diagnostic approaches, including Interferon-Gamma Release Assay (IGRA) and chest radiography, which is often very low. Computed tomography (CT) scanning, although not recommended by the World Health Organization (WHO) for TB diagnosis, may be of high interest in our high-income low-burden countries. This study assess the performance of the combination of CT scanning and IGRA to diagnose active pulmonary TB and identifies discriminatory CT scan features indicative of active disease.
Methods : A retrospective study was conducted on 580 patients clinically suspected of TB or in contact with bacteriologically confirmed cases (index cases). Patients underwent IGRA testing, thoracic CT scans, and respiratory (or other organs) samples culture. CT scan findings were blindly analyzed, and a composite score combining significant radiological signs with IGRA results was constructed. Diagnostic performance measures, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients clinically suspected of active tuberculosis or in contact with index cases | – | –patients had either a clinical suspicion of active tuberculosis or underwent screening due to a close contact with another patient which had a bacteriologically confirmed active tuberculosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients screened for tuberculosis at the Montpellier University Hospital
Key inclusion criteria (5 listed)
- Major patients who received the following examinations at the Montpellier University Hospital for tuberculosis screening (clinical suspicion and/or contact with a person with active tuberculosis):
- Chest X-ray AND
- Chest CT scan AND
- Mycobacteriology examination of respiratory or tissue sample (direct/culture/GenXpert) AND
- IGRA test (Quantiferon)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan
Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Sensitivity
Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan
Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
specificity
2 secondary outcomes
Positive Predictive value of the combination of IGRA and Chest CT scan
Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Negative Predictive value of the combination of IGRA and Chest CT scan
Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
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 9 May 2024.
- Individual participant dataSharing planned: No
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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.
Jérémy Charriot, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Active Tuberculosis and Latent Tuberculosis, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 0 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 9 May 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 France. 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?
Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan (time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2024.