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Completed

NCT Number: NCT04171128

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ostfold Hospital trust, Sarpsborg, Akershus, Norway

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About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient admitted to the hospital with positive influenza test

Exclusion criteria

  • none

Treatment and study plan

antibiotic stewardship efforts

Behavioral

The local antibiotic team plan to implement procalcitonin use among the hospital physicians. the interventions are not ready yet.

Primary outcomes

  1. 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

Secondary outcomes

  1. antibiotic use

    Time frame: up to one year

    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

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2019
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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