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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of
age) saliva swabs
Trial website
https://clinicaltrials.gov/ct2/show/NCT03251261
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03251261