Detection of Cytomegalovirus Virus in Neonates (CMV)

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

Study Overview

• Status: Completed
• Conditions: CMV
• Intervention / Treatment: Device: illumigene CMV assay, illumipro-10

• Study Type: Observational
• Enrollment (Actual): 1615

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • The Prince of Wales Hospital
• Canada
  • British Coloumbia
    • Vancouver, British Coloumbia, Canada, V6H 3N1
      • British Columbia Children's Hospital / British Columbia Women's Hospital
• Italy
  • Province Of Bologna
    • Via Massarenti 19, Province Of Bologna, Italy, 40138
      • Ospedale Sant'Orsola
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Saliva swab specimens from all neonates up to 21 days of age may be collected and tested

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative detection of CMV to aid in the diagnosis of CMV	Test each sample for CMV detection	within 30 days of sample collection

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.
• Investigators: Study Director: Julie M Kesler, Meridian Bioscience; Study Chair: Ken Kozak, Meridian Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): March 5, 2018

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CLIN-DHF-333-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes