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NCT01839760 Clinical Trial

Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients

Influenza Clinical Trial

Official title:
Prospective Study to Evaluate Viral Shedding Patterns and Clinical Outcomes of Hospitalized Adult Influenza Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01839760
Other study ID # FLU-EPI-001
Secondary ID
Status Completed
Phase N/A
First received April 8, 2013
Last updated August 21, 2014
Start date December 2012
Est. completion date January 2014

Study information
Verified date August 2014
Source Crucell Holland BV
Contact n/a
Is FDA regulated No
Health authority Canada: Ministry of Health & Long Term Care, OntarioUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent

- Hospitalized or admitted to ICU for influenza

- Age =18 years

- Laboratory confirmation of influenza A or B

Exclusion Criteria:

- Informed consent not given

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Westmead Hospital Westmead New South Wales
Canada Mount Sinai Hospital Toronto Ontario
Canada North York General Hospital Toronto Ontario
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Crucell Holland BV

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Viral load/Viral shedding Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) Day 7 No
Primary Viral load/Viral shedding Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) Day 9 No
Primary Viral load/Viral shedding Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) Day 11 No
Primary Viral load/Viral shedding Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) Day 13 No
Primary Viral load/Viral shedding Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) Day 15 No
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