Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients

NCT ID: NCT01839760

Last Updated: 2014-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inpatient cohort

Patients admitted to general wards

No interventions assigned to this group

ICU cohort

Patients admitted to ICU

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Crucell Holland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

North York General Hospital

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Australia Canada

Other Identifiers

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FLU-EPI-001

Identifier Type: -

Identifier Source: org_study_id

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