Evaluation of the QuantiFERON-TB Test.

Tuberculosis Clinical Trial

Official title:

Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142894
• Other study ID #: CST001_USA1
• Status: Completed
• Start date: May 27, 2014
• Est. completion date: March 28, 2016

Study information

• Verified date: June 2019
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 28, 2016
• Est. primary completion date: March 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Device:
• CST001

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity	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.	At time of enrollment