Detection of Cytomegalovirus Virus in Neonates

Completed

Conditions studied: CMV

In brief

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

Key facts

Study ID

NCT03251261

Run by

Meridian Bioscience, Inc.

People needed

1615

Starts

2017-08-02

Expected to finish

2018-03-05

Last updated by the study team

2019-01-14

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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