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

NCT ID: NCT06408129

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 580 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2024-04-09

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.

Conditions

Active Tuberculosis; Latent Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérémy Charriot, MD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

UH Montpellier

Montpellier, , France

Countries

France

Other Identifiers

IRB-MTP_2022_04_202201086

Identifier Type: -

Identifier Source: org_study_id