Serological Test for the Diagnosis of TB (MycoTB)

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

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.

Study Overview

• Status: Terminated
• Conditions: Active Tuberculosis
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital Montpellier Department of microbiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with active tuberculosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Immunosuppression

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive and negative predictive values for the diagnosis of active TB	48 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Edouard Tuaillon, MD; PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2013
• Primary Completion (Actual): December 20, 2014
• Study Completion (Actual): June 20, 2015

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 9179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO