Clinical Performance Evaluation of DxN CMV Assay

July 10, 2018 updated by: Beckman Coulter, Inc.
The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

same as brief summary

Study Type

Observational

Enrollment (Actual)

19

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
    • California
      • Los Angeles, California, United States
        • UCLA
    • Illinois
      • Chicago, Illinois, United States
        • NWU
    • Indiana
      • Indianapolis, Indiana, United States
        • IU
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo

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

Adult kidney transplant recipients undergoing CMV therapy

Description

Inclusion Criteria:

  • ≥ 18 years old
  • Must have had a kidney transplant and be evaluated for post-transplantation care
  • Must have demonstrated post-transplant CMV DNAemia
  • Must be eligible for and treated with anti-CMV drugs

Exclusion Criteria:

  • HIV positive
  • Proven ganciclovir or valganciclovir resistance

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
CMV infected
CMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care.
Diagnostic test: CMV Assay
Molecular diagnostic test to detect CMV
Other Names:
  • DxN CMV Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virological response to therapy
Time Frame: 5 months
Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results
5 months

Collaborators and Investigators

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

Sponsor

Beckman Coulter, Inc.

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)

June 1, 2016

Primary Completion (ACTUAL)

August 30, 2017

Study Completion (ACTUAL)

August 30, 2017

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CMV 2.7.3.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

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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