Serological Test for the Diagnosis of TB

Terminated

• Conditions: Active Tuberculosis

• Registration Number: NCT02898623
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB. The main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. Adult patients with possible TB from will be tested for the presence of antibodies directed against M. tuberculosis selected antigens. Positive and negative predictive values will be established based on TB culture results.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-20
• Primary Completion: 2014-12-20
• Study Completion: 2015-06-20
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Signs of possible Tuberculosis (TB); testing for TB in routine practice (microbiology)

Exclusion Criteria

• Immunosuppression

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and negative predictive values for the diagnosis of active TB	48 months

Trial Locations

Locations (1)

University Hospital Montpellier Department of microbiology; 🇫🇷 Montpellier, France