Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408129
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2024-04-09
Brief Title:
COMPArison of Screening Strategies for Active TuBerculosis COMPASS-TB
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
COMPArison of Screening Strategies for Active TuBerculosis COMPASS-TB
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPASS-TB
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None