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

Latent Tuberculosis Clinical Trial

— COMPASS-TB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06408129
• Other study ID #: IRB-MTP_2022_04_202201086
• Status: Completed
• Start date: January 31, 2017
• Est. completion date: April 9, 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: April 9, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Active Tuberculosis
• Latent Tuberculosis
• Tuberculosis

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan	Sensitivity	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Primary	Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan	specificity	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Secondary	Positive Predictive value of the combination of IGRA and Chest CT scan	Positive Predictive value	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Secondary	Negative Predictive value of the combination of IGRA and Chest CT scan	Negative Predictive value	Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis