Clinical trial NCT06408129: COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)
Official title: COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Active Tuberculosis
Latent Tuberculosis
Keywords: Active Tuberculosis
LAtent Tuberculosis infection
Interferon-Gamma Release Assay
Quantiferon
Chest CT scan
Chest X-ray
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients screened for tuberculosis at the Montpellier University Hospital

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan
timeFrame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
measure: Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan
timeFrame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Secondary outcomes:
measure: Positive Predictive value of the combination of IGRA and Chest CT scan
timeFrame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
measure: Negative Predictive value of the combination of IGRA and Chest CT scan
timeFrame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Jérémy Charriot, MD
role: STUDY_DIRECTOR
References: