Evaluation of Viral Shedding Patterns and Clinical Outcomes of 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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)
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)
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)
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)
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)

Sponsors and collaborators

Lead sponsor

Crucell Holland BV

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Apr 25, 2013
Registry last updated: Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed