CMVCMVNCT03251261
Detection of Cytomegalovirus Virus in Neonates
An observational study of CMV, run by Meridian Bioscience, Inc. at 5 sites in 4 countries.
Trial summary
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs Read more about this study
- Who is it for?
- Ages Up to 20 daysHealthy volunteers can take part
- Conditions the study is for
- CMV
- What is being tested?
- illumigene CMV assay, illumipro-10
- Type of treatment
- Medical device
- How many people
- 1,615 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 2 Aug 2017to 5 Mar 2018
- 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 Up to 20 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Saliva swab specimens from all neonates up to 21 days of age may be collected and tested
Who may be able to join
- Saliva swab specimens from neonates up to 21 days of age
- Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium.
- Flocked-nylon swabs
Who cannot join
- Samples other than saliva swab from patients up to 21 days of age.
- Swabs other than flocked-nylon.
- Swabs in a viral transport media not defined in the Investigational Use Only package insert
- Multiple specimens from the same patient.
- Specimens received in the laboratory in unsatisfactory containers or condition.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Utah
Salt Lake City, Utah, 84112
Australia1 site
The Prince of Wales Hospital
Randwick, New South Wales, 2031
Canada1 site
British Columbia Children's Hospital / British Columbia Women's Hospital
Vancouver, British Coloumbia, V6H 3N1
About this study
Official title: Illumigene CMV Clinical Trial Protocol
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs
- Conditions
- CMV
- Being tested
- illumigene CMV assay, illumipro-10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
illumigene CMV assay, illumipro-10Device
CMV assay for detection of CMV
| Study group | Role | What they receive |
|---|---|---|
| Specimen collection | Not described Receives: Device: illumigene CMV assay, illumipro-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative detection of CMV to aid in the diagnosis of CMV
Test each sample for CMV detection
Measured: within 30 days of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start2 Aug 2017
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies 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
- 1,615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie M Kesler, Study director, Meridian BioscienceKen Kozak, Study chair, Meridian Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251261
- Sponsor's protocol ID
- CLIN-DHF-333-001
- Acronym
- CMV
- Status last verified
- Jan 2019
- First submitted
- 14 Aug 2017
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illumigene CMV Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT03251261
- Acronym / sponsor ID
- CMV / CLIN-DHF-333-001
- Conditions
- CMV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,615 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 16 Aug 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.
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen collection | – | Device: illumigene CMV assay, illumipro-10 |
Who may qualify
- Ages
- Up to 20 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Saliva swab specimens from all neonates up to 21 days of age may be collected and tested
Key inclusion criteria (3 listed)
- Saliva swab specimens from neonates up to 21 days of age
- Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium.
- Flocked-nylon swabs
Key exclusion criteria (5 listed)
- Samples other than saliva swab from patients up to 21 days of age.
- Swabs other than flocked-nylon.
- Swabs in a viral transport media not defined in the Investigational Use Only package insert
- Multiple specimens from the same patient.
- Specimens received in the laboratory in unsatisfactory containers or condition.
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 |
|---|---|---|
| illumigene CMV assay, illumipro-10CMV assay for detection of CMV | Device | Specimen collection |
Primary outcome
Qualitative detection of CMV to aid in the diagnosis of CMV
Time frame: within 30 days of sample collection
Test each sample for CMV detection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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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.
Julie M Kesler study director
Meridian Bioscience
Ken Kozak study chair
Meridian Bioscience
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV, run by Meridian Bioscience, Inc. at 5 sites in 4 countries.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Canada, Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Qualitative detection of CMV to aid in the diagnosis of CMV (time frame: within 30 days of sample collection). 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 14 Jan 2019.