Clinical Evaluation of the QuantiFERON CMV Assay
Sponsor
QIAGEN Gaithersburg, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT03502161
Collaborator
(none)
8
1
19.5
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
8 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Evaluation of the QuantiFERON CMV Assay
Actual Study Start Date
:
Nov 15, 2018
Actual Primary Completion Date
:
May 15, 2020
Actual Study Completion Date
:
Jun 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All subjects Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis. |
Device: QuantiFERON CMV Assay
Assay to measure cell-mediated immune function using QuantiFERON CMV assay.
|
Outcome Measures
Primary Outcome Measures
- Change in time to CMV Infection between sub-groups of QF-CMV assay classifications. [At time of prophylaxis termination, +1 month from termination, +2 months from termination]
Measurement of QF-CMV result
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- QIAGEN Gaithersburg, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Tolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3.
Responsible Party:
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT03502161
Other Study ID Numbers:
- C16-CMV-001
First Posted:
Apr 18, 2018
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No