Serological Test for the Diagnosis of TB

Active Tuberculosis Clinical Trial

— MycoTB  

Official title:

Performances of Immunoassays Based on the Detection of Antibodies Directed Against Mycobacterium Tuberculosis Antigen for the Diagnosis of Active Tuberculosis in Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02898623
• Other study ID #: 9179
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Active Tuberculosis
• Tuberculosis

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