NCT02898623

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

September 8, 2016

Last Update Submit

December 9, 2021

Conditions

Active Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Positive and negative predictive values for the diagnosis of active TB

    48 months

Interventions

No interventionOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with active tuberculosis

You may qualify if:

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

You may not qualify if:

  • Immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Montpellier Department of microbiology

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Study Officials

  • Edouard Tuaillon, MD; PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

December 20, 2013

Primary Completion

December 20, 2014

Study Completion

June 20, 2015

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)