NCT01839760CompletedNot Applicable
Prospective Study to Evaluate Viral Shedding Patterns and Clinical Outcomes of Hospitalized Adult Influenza Patients
Crucell Holland BV5 sites in 3 countries150 target enrollmentStarted: December 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 5
- Primary Endpoint
- Viral load/Viral shedding
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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