Status:

COMPLETED

Detection of Cytomegalovirus Virus in Neonates

Lead Sponsor:

Meridian Bioscience, Inc.

Conditions:

CMV

Eligibility:

All Genders

Up to 20 years

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 2 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 5 2018

Estimated Enrollment :

1615 Patients enrolled

Trial Details

Trial ID

NCT03251261

Start Date

August 2 2017

End Date

March 5 2018

Last Update

January 14 2019

Active Locations (5)

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Page 1 of 2 (5 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

2

University of Utah

Salt Lake City, Utah, United States, 84112

3

The Prince of Wales Hospital

Randwick, New South Wales, Australia, 2031

4

British Columbia Children's Hospital / British Columbia Women's Hospital

Vancouver, British Coloumbia, Canada, V6H 3N1