InfluenzaNCT01839760
Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients
An observational study of Influenza, run by Crucell Holland BV at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- How many people
- 150 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Dec 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adult patients with laboratory-confirmed influenza A or B
Who may be able to join
- Written informed consent
- Hospitalized or admitted to ICU for influenza
- Age ≥18 years
- Laboratory confirmation of influenza A or B
Who cannot join
- Informed consent not given
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Westmead Hospital
Westmead, New South Wales, 2145
Canada2 sites
North York General Hospital
Toronto, Ontario, M2K 1E1
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
Official title: Prospective Study to Evaluate Viral Shedding Patterns and Clinical Outcomes of Hospitalized Adult 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.
- Conditions
- Influenza
- Keywords
- Influenza, Virus, Viral shedding, Epidemiology
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient cohort | Patients admitted to general wards | |
| ICU cohort | Patients admitted to ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load/Viral shedding
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Measured: Day 7
Viral load/Viral shedding
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Measured: Day 9
Viral load/Viral shedding
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Measured: Day 11
Viral load/Viral shedding
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Measured: Day 13
Viral load/Viral shedding
Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839760
- Sponsor's protocol ID
- FLU-EPI-001
- Status last verified
- Aug 2014
- First submitted
- 8 Apr 2013
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate Viral Shedding Patterns and Clinical Outcomes of Hospitalized Adult Influenza Patients
- ClinicalTrials.gov ID
- NCT01839760
- Acronym / sponsor ID
- FLU-EPI-001
- Conditions
- Influenza
- Keywords
- Influenza, Virus, Viral shedding, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient cohort | – | –Patients admitted to general wards |
| ICU cohort | – | –Patients admitted to ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients with laboratory-confirmed influenza A or B
Key inclusion criteria (4 listed)
- Written informed consent
- Hospitalized or admitted to ICU for influenza
- Age ≥18 years
- Laboratory confirmation of influenza A or B
Key exclusion criteria (1 listed)
- Informed consent not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Crucell Holland BV at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load/Viral shedding (time frame: Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.