NCT03251261

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,615

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

August 14, 2017

Last Update Submit

January 11, 2019

Conditions

CMV

Outcome Measures

Primary Outcomes (1)

  • Qualitative detection of CMV to aid in the diagnosis of CMV

    Test each sample for CMV detection

    within 30 days of sample collection

Study Arms (1)

Specimen collection

Device: illumigene CMV assay, illumipro-10

Interventions

illumigene CMV assay, illumipro-10DEVICE

CMV assay for detection of CMV

Specimen collection

Eligibility Criteria

AgeUp to 20 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

The Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

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

Vancouver, British Coloumbia, V6H 3N1, Canada

Location

Ospedale Sant'Orsola

Via Massarenti 19, Province of Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Prospectively collected saliva swabs from neonates up to 21 days of age Retrospective well characterized positive saliva samples will also be tested

Study Officials

  • Julie M Kesler

    Meridian Bioscience

    STUDY DIRECTOR

  • Ken Kozak

    Meridian Bioscience

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 16, 2017

Study Start

August 2, 2017

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

US(2)CA(1)AU(1)IT(1)