Active Tuberculosis Clinical Trial
— MycoTBOfficial title:
Performances of Immunoassays Based on the Detection of Antibodies Directed Against Mycobacterium Tuberculosis Antigen for the Diagnosis of Active Tuberculosis in Adults
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 |
Verified date | December 2021 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Montpellier Department of microbiology | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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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