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Completed

NCT Number: NCT06408129

COMPArison of Screening Strategies for Active TuBerculosis (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UH Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan

    Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis

    Sensitivity

  2. Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan

    Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis

    specificity

Secondary outcomes

  1. Positive Predictive value of the combination of IGRA and Chest CT scan

    Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis

    Positive Predictive value

  2. Negative Predictive value of the combination of IGRA and Chest CT scan

    Time frame: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis

    Negative Predictive value

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: COMPASS-TB

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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