Clinical Evaluation of the QuantiFERON CMV Assay

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03502161

Enrollment

Registered

2018-04-18

Start date

2018-11-15

Completion date

2020-06-30

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV

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.

Interventions

DEVICEQuantiFERON CMV Assay

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026