NCT01839760

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

1.1 years

First QC Date

April 8, 2013

Last Update Submit

August 21, 2014

Conditions

Influenza

Keywords

InfluenzaVirusViral sheddingEpidemiology

Outcome Measures

Primary Outcomes (5)

  • Viral load/Viral shedding

    Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)

    Day 7

  • Viral load/Viral shedding

    Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)

    Day 9

  • Viral load/Viral shedding

    Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)

    Day 11

  • Viral load/Viral shedding

    Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)

    Day 13

  • Viral load/Viral shedding

    Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)

    Day 15

Study Arms (2)

Inpatient cohort

Patients admitted to general wards

ICU cohort

Patients admitted to ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized adult patients with laboratory-confirmed influenza A or B

You may qualify if:

  • Written informed consent
  • Hospitalized or admitted to ICU for influenza
  • Age ≥18 years
  • Laboratory confirmation of influenza A or B

You may not qualify if:

  • Informed consent not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Influenza, HumanVirus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 25, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

AU(2)CA(2)US(1)