Clinical Evaluation of the QuantiFERON CMV Assay

September 14, 2020 updated by: QIAGEN Gaithersburg, Inc
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CMV D+/R- SOT recipients older than 18 that are receiving 3-6 months of antiviral prophylaxis and can provide Informed Consent.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At time of prophylaxis termination, +1 month from termination, +2 months from termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QIAGEN Gaithersburg, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2018

Primary Completion (ACTUAL)

May 15, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • C16-CMV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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