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NCT03127787 Clinical Trial

Clinical Performance Evaluation of DxN CMV Assay

Cytomegalovirus Clinical Trial

Official title:
Clinical Performance Evaluation of DxN CMV Assay

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03127787
Other study ID # CMV 2.7.3.001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 2016
Est. completion date August 30, 2017

Study information
Verified date July 2018
Source Beckman Coulter, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

same as brief summary

Recruitment information / eligibility
Status Terminated
Enrollment 19
Est. completion date August 30, 2017
Est. primary completion date August 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CMV Assay
Molecular diagnostic test to detect CMV

Locations
Country Name City State
United States NWU Chicago Illinois
United States IU Indianapolis Indiana
United States UCLA Los Angeles California
United States Mayo Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary virological response to therapy Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results 5 months
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