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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02898623
Other study ID # 9179
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 20, 2013
Est. completion date June 20, 2015

Study information

Verified date December 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1000
Est. completion date June 20, 2015
Est. primary completion date December 20, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signs of possible Tuberculosis (TB); testing for TB in routine practice (microbiology) Exclusion Criteria: - Immunosuppression

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
Evaluation of performance of immunoassays based on the detection of antibodies directed against Mycobacterium tuberculosis antigen

Locations

Country Name City State
France University Hospital Montpellier Department of microbiology Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Positive and negative predictive values for the diagnosis of active TB 48 months
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