Compliance of Initial Empiric Antimicrobial Therapy

NCT ID: NCT04448665

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-02-15

Brief Summary

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Hospital infections comprise about half of all undesirable complications related to hospital treatment. In case of bacterial infection administration of antimicrobial agent is a therapy of choice. For maximum effectiveness, antimicrobial agents should be administered quickly in optimal doses. Moreover, the therapeutic concentration of properly selected drugs should be achieved as soon as possible. The relation between delays in the administration of antibiotics and increased mortality is well known. That is why proper empiric therapy is so important. Before antimicrobial investigation is completed, which may last up to 72 hours, a wide-spectrum antimicrobial should be administered according to the type of infection, its origin, and the characteristics of the local pathogens.

The objective of this study is to compare the initial choice of empiric antimicrobial therapy and the results of both microbiological identification and susceptibility/resistance analysis of isolated pathogens.

This project was designed as a prospective cohort study. Analysis was performed in a large multidisciplinary academic hospital and trauma center. All decisions on empiric therapy with antimicrobial used in infections caused by multidrug-resistant pathogens, that are made in different hospital wards except intensive care, are required by hospital procedures to be confirmed by intensivists. In our analysis, the initial choice of empiric therapy in the hospital wards other than the critical care unit was compared with the results of microbiological investigations and susceptibility/resistance analyses of isolated pathogens.

Accurate microbial identification was performed with a VITEKĀ® 2 automatic testing system. The microbroth dilution method with VITEKĀ® 2 AST cards was used for the antibiotic susceptibility testing of isolated pathogens.

Microbiological analyses were performed between 2018 and 2020 according to the regulations of the European Committee on Antimicrobial Susceptibility (EUCAST, version 9.0, 2019) and the National Reference Centre for Susceptibility Testing (NRCST, Warsaw, Poland).

Detailed Description

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Conditions

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Anti-Infective Agents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with suspected infection

The hospitalized patients in whom, based on clinical signs and symptoms, an infection is suspected, and an administration of antimicrobial agents as empiric therapy is necessary.

microbiological investigation

Intervention Type DIAGNOSTIC_TEST

a microbiological tests, including isolation of the pathogen and analysis of their susceptibility/resistance to antimicrobial agents

Interventions

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microbiological investigation

a microbiological tests, including isolation of the pathogen and analysis of their susceptibility/resistance to antimicrobial agents

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Eligibility Criteria:

\- all patients in whom, based on clinical signs and symptoms, an infection is suspected, and an administration of antimicrobial agents as empiric therapy was necessary

Eclusion Criteria:

\- none.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Institute od Medicine National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Dariusz Tomaszewski

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dariusz Tomaszewski, MD, PhD

Role: STUDY_DIRECTOR

Department of Anesthesiology and Intensive Therapy

Locations

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Department of Anesthesiology and Intensive Therapy

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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681006-08

Identifier Type: -

Identifier Source: org_study_id

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