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/show/NCT01839760




Registration number
NCT01839760
Ethics application status
Date submitted
8/04/2013
Date registered
25/04/2013
Date last updated
22/08/2014

Titles & IDs
Public title
Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients
Scientific title
Prospective Study to Evaluate Viral Shedding Patterns and Clinical Outcomes of Hospitalized Adult Influenza Patients
Secondary ID [1] 0 0
FLU-EPI-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 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
Inpatient cohort - Patients admitted to general wards

ICU cohort - Patients admitted to ICU

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Viral load/Viral shedding - Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Timepoint [1] 0 0
Day 7
Primary outcome [2] 0 0
Viral load/Viral shedding - Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Timepoint [2] 0 0
Day 9
Primary outcome [3] 0 0
Viral load/Viral shedding - Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Timepoint [3] 0 0
Day 11
Primary outcome [4] 0 0
Viral load/Viral shedding - Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Timepoint [4] 0 0
Day 13
Primary outcome [5] 0 0
Viral load/Viral shedding - Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Timepoint [5] 0 0
Day 15

Eligibility
Key inclusion criteria
- Written informed consent

- Hospitalized or admitted to ICU for influenza

- Age =18 years

- Laboratory confirmation of influenza A or B
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Informed consent not given

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Crucell Holland BV
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the study is virological assessment (e.g., proportion of prolonged viral
shedding, median days to viral clearance, and viral load) in laboratory-confirmed adult
influenza patients admitted to the general ward and/or to the ICU and to assess the
correlation with the clinical manifestations and prognosis.
Trial website
https://clinicaltrials.gov/show/NCT01839760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
Other publications