Clinical Performance Evaluation of DxN CMV Assay
Terminated
- Conditions
- Cytomegalovirus
- Interventions
- Diagnostic Test: CMV Assay
- Registration Number
- NCT03127787
- Lead Sponsor
- Beckman Coulter, Inc.
- Brief 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.
- Detailed Description
same as brief summary
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CMV infected CMV Assay CMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care.
- Primary Outcome Measures
Name Time Method virological response to therapy 5 months Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
IU
🇺🇸Indianapolis, Indiana, United States
UCLA
🇺🇸Los Angeles, California, United States
NWU
🇺🇸Chicago, Illinois, United States
Mayo
🇺🇸Rochester, Minnesota, United States