CytomegalovirusNCT03127787
Clinical Performance Evaluation of DxN CMV Assay
An observational study of Cytomegalovirus, run by Beckman Coulter, Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus
- What is being tested?
- CMV Assay
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2016to 30 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult kidney transplant recipients undergoing CMV therapy
Who may be able to join
- ≥ 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
Who cannot join
- HIV positive
- Proven ganciclovir or valganciclovir resistance
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NWU
Chicago, Illinois
IU
Indianapolis, Indiana
UCLA
Los Angeles, California
Mayo
Rochester, Minnesota
About this study
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.
Read the detailed description
same as brief summary
- Conditions
- Cytomegalovirus
- Being tested
- CMV Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV AssayDiagnostic test
Also called DxN CMV Assay
Molecular diagnostic test to detect CMV
| Study group | Role | What they receive |
|---|---|---|
| CMV infected | CMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care. Receives: Diagnostic Test: CMV Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
virological response to therapy
Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startJun 2016
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytomegalovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127787
- Sponsor's protocol ID
- CMV 2.7.3.001
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2017
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of DxN CMV Assay
- ClinicalTrials.gov ID
- NCT03127787
- Acronym / sponsor ID
- CMV 2.7.3.001
- Conditions
- Cytomegalovirus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV infected | – | Diagnostic Test: CMV AssayCMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney transplant recipients undergoing CMV therapy
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- HIV positive
- Proven ganciclovir or valganciclovir resistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV AssayAlso: DxN CMV AssayMolecular diagnostic test to detect CMV | Diagnostic test | CMV infected |
Primary outcome
virological response to therapy
Time frame: 5 months
Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Cytomegalovirus
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Cytomegalovirus Infections, Primary Immune Deficiency Disorder
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus, run by Beckman Coulter, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virological response to therapy (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.