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NCT03502161 Clinical Trial

Clinical Evaluation of the QuantiFERON CMV Assay

CMV Clinical Trial

Official title:
Clinical Evaluation of the QuantiFERON CMV Assay

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03502161
Other study ID # C16-CMV-001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 15, 2018
Est. completion date June 30, 2020

Study information
Verified date September 2020
Source QIAGEN Gaithersburg, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date June 30, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.

- Scheduled to receive between 3 to 6 months of antiviral prophylaxis

- Provide Informed Consent

Exclusion Criteria:

- Subjects less than 18 years old

- Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis

- Unable to provide Informed Consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• QuantiFERON CMV Assay
Assay to measure cell-mediated immune function using QuantiFERON CMV assay.

Locations
Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001 Mar 1;32(5):742-51. Epub 2001 Feb 20. Review. — View Citation

Tolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in time to CMV Infection between sub-groups of QF-CMV assay classifications. Measurement of QF-CMV result At time of prophylaxis termination, +1 month from termination, +2 months from termination
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