Evaluation of the QuantiFERON-TB Test.

NCT ID: NCT02142894

Last Updated: 2019-06-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-27

Study Completion Date

2016-03-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Tuberculosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic

Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.

CST001

Intervention Type DEVICE

Interventions

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CST001

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brenda Jones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

Other Identifiers

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CST001_USA1

Identifier Type: -

Identifier Source: org_study_id

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