Evaluation of the QuantiFERON-TB Test.

Completed

• Conditions: Tuberculosis
• Interventions: Device: CST001

• Registration Number: NCT02142894
• Lead Sponsor: QIAGEN Gaithersburg, Inc

Brief Summary

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

Detailed Description

The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.

Study Timeline

• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Study Start: 2014-05-27
• Primary Completion: 2016-03-28
• Study Completion: 2016-03-28
• Results First Submitted: 2018-09-18
• Results First Submitted QC: 2019-02-27
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Results First Posted: 2019-06-06
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Clinical symptoms consistent with a high probability of having TB disease
• Receiving, or are likely to receive, therapy for active TB
• Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
• Between 18 and 70 years of age.

Exclusion Criteria

• Taken therapy for active TB or latent TB for more than 14 days
• Culture confirmation of M. tuberculosis not obtained

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic	CST001	Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity	At time of enrollment	To evaluate the clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms strongly indicating TB disease and who are receiving or have to start treatment for active TB, and whom Mycobacterium tuberculosis (MTB) is confirmed by bacteriological culture. Patients included in the testing either had a positive acid-fast bacillus (AFB) smear of have MTB in a specimen detected by nucleic acid amplification (NAA) of MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States