Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients

August 21, 2014 updated by: Crucell Holland BV

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized adult patients with laboratory-confirmed influenza A or B

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Inpatient cohort
Patients admitted to general wards
ICU cohort
Patients admitted to ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral load/Viral shedding
Time Frame: Day 7
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Day 7
Viral load/Viral shedding
Time Frame: Day 9
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Day 9
Viral load/Viral shedding
Time Frame: Day 11
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Day 11
Viral load/Viral shedding
Time Frame: Day 13
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Day 13
Viral load/Viral shedding
Time Frame: Day 15
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crucell Holland BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLU-EPI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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