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NCT04171128 Clinical Trial

Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use

Influenza Clinical Trial

Official title:
Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04171128
Other study ID # AB3420-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2019
Est. completion date August 1, 2020

Study information
Verified date March 2021
Source Ostfold Hospital Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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").

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date August 1, 2020
Est. primary completion date February 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient admitted to the hospital with positive influenza test Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• antibiotic stewardship efforts
The local antibiotic team plan to implement procalcitonin use among the hospital physicians. the interventions are not ready yet.

Locations
Country Name City State
Norway Ostfold Hospital Trust Sarpsborg Ostfold
Norway Ostfold Hospital trust Sarpsborg Viken

Sponsors (1)
Lead Sponsor Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 30 days
Secondary 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 up to one year
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