Clinical Performance Evaluation of DxN CMV Assay

Stopped early

Conditions studied: Cytomegalovirus

In brief

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.

Key facts

Study ID

NCT03127787

Run by

Beckman Coulter, Inc.

People needed

19

Starts

2016-06-01

Expected to finish

2017-08-30

Last updated by the study team

2018-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• HIV positive
• Proven ganciclovir or valganciclovir resistance

Where it is running

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

Full record on ClinicalTrials.gov

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