Detection of Cytomegalovirus Virus in Neonates | NCT03251261

Studies
Detection of Cytomegalovirus Virus in Neonates

NCT03251261

Sponsor

Meridian Bioscience, Inc.

Status

Completed

Last Update Posted

Jan 14, 2019Actual

Enrollment

1,615Actual

Phase

Not provided

Conditions

Interventions

illumigene CMV assay, illumipro-10

Countries

United States
Australia
Canada
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2017Actual

Primary Completion Date

Mar 5, 2018Actual

Completion Date

Mar 5, 2018Actual

First Submitted Date

Aug 14, 2017

First Submission Date that Met QC Criteria

Aug 15, 2017

First Posted Date

Aug 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2019

Last Update Posted Date

Jan 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,615Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Specimen collection			Device: illumigene CMV assay, illumipro-10

Interventions

Name	Type	Description	Arm Group Labels	Other Names
illumigene CMV assay, illumipro-10	Device	CMV assay for detection of CMV	Specimen collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative detection of CMV to aid in the diagnosis of CMV	Test each sample for CMV detection	within 30 days of sample collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Days

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie M Kesler	Meridian Bioscience	Study Director
Ken Kozak	Meridian Bioscience	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
University of Utah