Skip to content

COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)

COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06408129
Acronym
COMPASS-TB
Enrollment
580
Registered
2024-05-09
Start date
2017-01-31
Completion date
2024-04-09
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Tuberculosis, Latent Tuberculosis

Keywords

Active Tuberculosis, LAtent Tuberculosis infection, Interferon-Gamma Release Assay, Quantiferon, Chest CT scan, Chest X-ray

Brief summary

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scanOver 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosisSensitivity
Diagnostic performance (specificity) of the combination of IGRA and Chest CT scanOver 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosisspecificity

Secondary

MeasureTime frameDescription
Positive Predictive value of the combination of IGRA and Chest CT scanOver 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosisPositive Predictive value
Negative Predictive value of the combination of IGRA and Chest CT scanOver 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosisNegative Predictive value

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026