Overview

This trial is active, not recruiting.

Condition tuberculosis
Treatment cst_001
Sponsor QIAGEN Gaithersburg, Inc
Start date October 2014
End date November 2016
Trial size 260 participants
Trial identifier NCT02256839, CST001_USA4

Summary

To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Group tested with CST_001
cst_001
Group tested with CST_001
cst_001

Primary Outcomes

Measure
Determination of TB Infection
time frame: 1 day (At time of enrollment)

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Low-exposure Risk Group Inclusion Criteria: - No identified risk factors for TB infection Exclusion Criteria: - Age less than 18 years or greater than 80 years - Identified Risk Factors For TB Infection Non-tuberculous mycobacterial infection Group Inclusion Criteria: - history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria Exclusion Criteria: - Age less than 18 years or greater than 80 years - Identified Risk Factors For TB Infection

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by QIAGEN Gaithersburg, Inc.