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Trial record 2 of 27 for:    CMV and Utah

Detection of Cytomegalovirus Virus in Neonates (CMV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03251261
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Meridian Bioscience, Inc.

Brief Summary:
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs

Condition or disease Intervention/treatment
CMV Device: illumigene CMV assay, illumipro-10

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Illumigene CMV Clinical Trial Protocol
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Group/Cohort Intervention/treatment
Specimen collection Device: illumigene CMV assay, illumipro-10
CMV assay for detection of CMV




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Prospectively collected saliva swabs from neonates up to 21 days of age Retrospective well characterized positive saliva samples will also be tested


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Ages Eligible for Study:   up to 20 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Saliva swab specimens from all neonates up to 21 days of age may be collected and tested
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251261


Contacts
Contact: Director Clinical Operations, BS, MBA 513271-3700 ext 574 julie.kesler@meridianbioscience.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Misty Purser    205-276-2649    mlpurser@uab.edu   
Principal Investigator: Suresh B. Boppana, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Heather Thiesset, MPH    801-581-5318    heather.thiesset@hsc.utah.edu   
Principal Investigator: Albert H Park, MD         
Australia, New South Wales
The Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Susanne Booth    +61-2 9382 9188    Susanne.Booth@health.nsw.gov.au   
Principal Investigator: William D Rawlinson, Professor         
Canada, British Coloumbia
British Columbia Children's Hospital / British Columbia Women's Hospital Recruiting
Vancouver, British Coloumbia, Canada, V6H 3N1
Contact: Ashley Cosgrove, MHA    +1 604 875 2669    acosgrove@bcchr.ubc.ca   
Principal Investigator: Soren M. Gantt, MD         
Italy
Ospedale Sant'Orsola Recruiting
Via Massarenti 19, Province Of Bologna, Italy, 40138
Principal Investigator: Tiziana Lazzarotto, Professor         
Sponsors and Collaborators
Meridian Bioscience, Inc.
Investigators
Study Director: Julie M Kesler Meridian Bioscience
Study Chair: Ken Kozak Meridian Bioscience

Responsible Party: Meridian Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT03251261     History of Changes
Other Study ID Numbers: CLIN-DHF-333-001
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes