Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients

Completed

• Conditions: Influenza

• Registration Number: NCT01839760
• Lead Sponsor: Crucell Holland BV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral load/Viral shedding	Day 15	Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)

Trial Locations

Locations (5)

North York General Hospital; 🇨🇦 Toronto, Ontario, Canada

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada