NCT03502161TerminatedNot Applicable
Clinical Evaluation of the QuantiFERON CMV Assay
QIAGEN Gaithersburg, Inc1 site in 1 country8 target enrollmentStarted: November 15, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.
Time Frame: At time of prophylaxis termination, +1 month from termination, +2 months from termination
Measurement of QF-CMV result
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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