Clinical Evaluation of the QuantiFERON CMV Assay

Terminated

• Conditions: CMV
• Interventions: Device: QuantiFERON CMV Assay

• Registration Number: NCT03502161
• Lead Sponsor: QIAGEN Gaithersburg, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Study Start: 2018-11-15
• Primary Completion: 2020-05-15
• Study Completion: 2020-06-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	QuantiFERON CMV Assay	Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States