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

NCT06408129 | Completed

• 1 other identifier: IRB-MTP_2022_04_202201086
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Tuberculosis; Latent Tuberculosis

Keywords

Active Tuberculosis; LAtent Tuberculosis infection; Interferon-Gamma Release Assay; Quantiferon; Chest CT scan; Chest X-ray

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Positive Predictive value of the combination of IGRA and Chest CT scan

  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

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major patients screened for tuberculosis at the Montpellier University Hospital

You may qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Jérémy Charriot, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 9, 2024
• Study Start: January 31, 2017
• Primary Completion: December 31, 2022
• Study Completion: April 9, 2024
• Last Updated: May 9, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)