- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02898623
Serological Test for the Diagnosis of TB (MycoTB)
December 9, 2021 updated by: University Hospital, Montpellier
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
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montpellier, France, 34295
- University Hospital Montpellier Department of microbiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive and negative predictive values for the diagnosis of active TB
Time Frame: 48 months
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48 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edouard Tuaillon, MD; PhD, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- 9179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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