Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03251261




Registration number
NCT03251261
Ethics application status
Date submitted
14/08/2017
Date registered
16/08/2017
Date last updated
14/01/2019

Titles & IDs
Public title
Detection of Cytomegalovirus Virus in Neonates
Scientific title
Illumigene CMV Clinical Trial Protocol
Secondary ID [1] 0 0
CLIN-DHF-333-001
Universal Trial Number (UTN)
Trial acronym
CMV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CMV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - illumigene CMV assay, illumipro-10

Specimen collection -


Treatment: Devices: illumigene CMV assay, illumipro-10
CMV assay for detection of CMV
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Qualitative detection of CMV to aid in the diagnosis of CMV
Timepoint [1] 0 0
within 30 days of sample collection

Eligibility
Key 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
Minimum age
No limit
Maximum age
20 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2018
Sample size
Target
Accrual to date
Final
1615
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Utah
Country [3] 0 0
Canada
State/province [3] 0 0
British Coloumbia
Country [4] 0 0
Italy
State/province [4] 0 0
Province Of Bologna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Meridian Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julie M Kesler
Address 0 0
Meridian Bioscience
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03251261