Serological Test for the Diagnosis of TB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-20

Study Completion Date

2015-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Active Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

Evaluation of performance of immunoassays based on the detection of antibodies directed against Mycobacterium tuberculosis antigen

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Immunosuppression

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edouard Tuaillon, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University Hospital Montpellier Department of microbiology

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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9179

Identifier Type: -

Identifier Source: org_study_id