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

Completed

• Conditions: Active Tuberculosis; Latent Tuberculosis

• Registration Number: NCT06408129
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2017-01-31
• Primary Completion: 2022-12-31
• Status Verified: 2023-03
• Study Completion: 2024-04-09
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis	specificity
Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis	Sensitivity

Secondary Outcome Measures

Name	Time	Method
Positive Predictive value of the combination of IGRA and Chest CT scan	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis	Positive Predictive value
Negative Predictive value of the combination of IGRA and Chest CT scan	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis	Negative Predictive value

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France