Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use
Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use
Sponsors
Source
Ostfold Hospital Trust
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief 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.
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").
Overall Status
Not yet recruiting
Start Date
2019-11-15
Completion Date
2020-08-01
Primary Completion Date
2020-04-15
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
mortality |
30 days |
Secondary Outcome
Measure |
Time Frame |
|
antibiotic use |
up to one year |
Enrollment
250
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
The local antibiotic team plan to implement procalcitonin use among the hospital physicians. the interventions are not ready yet.
Eligibility
Study Pop
seasonal influenza patients, adult population
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- patient admitted to the hospital with positive influenza test
Exclusion Criteria:
- none
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Contact
Location
Facility |
Status |
|
Ostfold Hospital Trust Sarpsborg Ostfold Norway |
Active, not recruiting |
Location Countries
Country
Norway
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Anti-Bacterial Agents
Antibiotics, Antitubercular
Firstreceived Results Date
N/A
Overall Contact Backup
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Only
Time Perspective
Prospective
Study First Submitted
November 14, 2019
Study First Submitted Qc
November 18, 2019
Study First Posted
November 20, 2019
Last Update Submitted
November 18, 2019
Last Update Submitted Qc
November 18, 2019
Last Update Posted
November 20, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.