InfluenzaNCT04171128
Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use
An observational study of Influenza, run by Ostfold Hospital Trust at 2 sites in Norway.
Trial summary
The investigators intend to observe the inflammatory marker procalcitonin (PCT) in comparison with patient variables on morbidity, mortality and antibiotic treatment. The overall aim is to observe if a low PCT value can have potential in reducing unessesary antibiotic use in seasonal influenza patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- antibiotic stewardship efforts
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 2 sitesNorway
- Study dates
- 2 Feb 2019to 1 Aug 2020
- 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: seasonal influenza patients, adult population
Who may be able to join
- patient admitted to the hospital with positive influenza test
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ostfold Hospital trust
Sarpsborg, Akershus, 1714
Ostfold Hospital Trust
Sarpsborg, Østfold fylke
About this study
The investigators intend to observe the inflammatory marker procalcitonin (PCT) in comparison with patient variables on morbidity, mortality and antibiotic treatment.
The overall aim is to observe if a low PCT value can have potential in reducing unessesary antibiotic use in seasonal influenza patients.
Read the detailed description
This is an observational study of the clinical utility of early PCT measurements in seasonal influenza, with particular attention to PCT's predictive value for prognosis and bacterial respiratory superinfection. The aim is to evaluate PCT as a supplementary aid in the standard clinical evaluation of influenza patients. Patients may be included if a positive influenza test is reported within 48 hours after an initial clinical suspicion of influenza, and the hospital stay is lasting more than one day. The investigators have included 74 patients from the second half of the 2018-19 influenza season and will continue to include patients from the complete 2019-20 season.
Primary endpoints: Mortality (in-hospital and within 30 days post-discharge), bacterial respiratory tract superinfection.
Secondary endpoints: Intensive care unit stay, the proportion of patients on antibiotic use and total antibiotic use in doses and LOT ("length-of-treatment").
- Conditions
- Influenza
- Being tested
- antibiotic stewardship efforts
- Keywords
- procalcitonin
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic stewardship effortsBehavioural
The local antibiotic team plan to implement procalcitonin use among the hospital physicians. the interventions are not ready yet.
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
From the national registry the investigators will register wheather or not the patient has died within day 14 and day 30, and in case of dead the date will be registered
Measured: 30 days
Secondary outcomes (1)
antibiotic use
From a elecronical medical chart (Metavision) the investigators will search and register the type of antibiotic used, the days of treatment and the total dose given in grams
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start2 Feb 2019
- Primary completion14 Feb 2020
- Study completion1 Aug 2020
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid christensen, MD, Principal investigator, Ostfold hospital trust, Kalnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171128
- Sponsor's protocol ID
- AB3420-3
- Status last verified
- Mar 2021
- First submitted
- 14 Nov 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use
- ClinicalTrials.gov ID
- NCT04171128
- Acronym / sponsor ID
- AB3420-3
- Conditions
- Influenza
- Keywords
- procalcitonin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- 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 investigators intend to observe the inflammatory marker procalcitonin (PCT) in comparison with patient variables on morbidity, mortality and antibiotic treatment.
The overall aim is to observe if a low PCT value can have potential in reducing unessesary antibiotic use in seasonal influenza patients.
Detailed description
This is an observational study of the clinical utility of early PCT measurements in seasonal influenza, with particular attention to PCT's predictive value for prognosis and bacterial respiratory superinfection. The aim is to evaluate PCT as a supplementary aid in the standard clinical evaluation of influenza patients. Patients may be included if a positive influenza test is reported within 48 hours after an initial clinical suspicion of influenza, and the hospital stay is lasting more than one day. The investigators have included 74 patients from the second half of the 2018-19 influenza season and will continue to include patients from the complete 2019-20 season.
Primary endpoints: Mortality (in-hospital and within 30 days post-discharge), bacterial respiratory tract superinfection.
Secondary endpoints: Intensive care unit stay, the proportion of patients on antibiotic use and total antibiotic use in doses and LOT ("length-of-treatment").
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- seasonal influenza patients, adult population
Key inclusion criteria (1 listed)
- patient admitted to the hospital with positive influenza test
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic stewardship effortsThe local antibiotic team plan to implement procalcitonin use among the hospital physicians. the interventions are not ready yet. | Behavioural | – |
Primary outcome
mortality
Time frame: 30 days
From the national registry the investigators will register wheather or not the patient has died within day 14 and day 30, and in case of dead the date will be registered
1 secondary outcome
antibiotic use
Time frame: up to one year
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 16 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Ingrid christensen, MD principal investigator
Ostfold hospital trust, Kalnes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Ostfold Hospital Trust at 2 sites in Norway.
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 1 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
mortality (time frame: 30 days). 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 16 Mar 2021.