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

The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.

Study Overview

• Status: Completed
• Conditions: Latent Tuberculosis; 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 Type: Observational
• Enrollment (Actual): 580

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Major patients screened for tuberculosis at the Montpellier University Hospital

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Jérémy Charriot, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): April 9, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Quantiferon; Chest X-ray; Active Tuberculosis; Chest CT scan; LAtent Tuberculosis infection; Interferon-Gamma Release Assay
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: IRB-MTP_2022_04_202201086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No