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NCT03251261 Clinical Trial

Detection of Cytomegalovirus Virus in Neonates

CMV Clinical Trial

— CMV  

Official title:
Illumigene CMV Clinical Trial Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03251261
Other study ID # CLIN-DHF-333-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2, 2017
Est. completion date March 5, 2018

Study information
Verified date January 2019
Source Meridian Bioscience, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1615
Est. completion date March 5, 2018
Est. primary completion date March 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 20 Days
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• illumigene CMV assay, illumipro-10
CMV assay for detection of CMV

Locations
Country Name City State
Australia The Prince of Wales Hospital Randwick New South Wales
Canada British Columbia Children's Hospital / British Columbia Women's Hospital Vancouver British Coloumbia
Italy Ospedale Sant'Orsola Via Massarenti 19 Province Of Bologna
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Utah Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Meridian Bioscience, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative detection of CMV to aid in the diagnosis of CMV Test each sample for CMV detection within 30 days of sample collection
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