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OpenTrials
Completed

NCT Number: NCT03251261

Detection of Cytomegalovirus Virus in Neonates

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

Completed

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Key information

Conditions

CMV

Age range

Up to 20 day

Sex eligibility

All sexes

Study type

Observational

Primary location

The Prince of Wales Hospital, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

illumigene CMV assay, illumipro-10

Device

CMV assay for detection of CMV

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Registry information

Official study title

Illumigene CMV Clinical Trial Protocol

Acronym: CMV

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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