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OpenTrials
Completed

NCT Number: NCT04448665

Compliance of Initial Empiric Antimicrobial Therapy

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 VITEK® 2 automatic testing system. The microbroth dilution method with VITEK® 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Therapy

Warsaw, 04-141, Poland

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

microbiological investigation

Diagnostic Test

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

Primary outcomes

  1. Accuracy of initial empiric therapy

    Time frame: Immediately after the completion of microbiological analyses

    The comparison of initially administered antimicrobial agent with the results of microbiological analyses (susceptibility/resistance of the isolated pathogen).

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

The Empiric Antimicrobial Therapy: the Comparison of Initial Clinical Choice of Drugs With the Results of Microbiological Investigations - an Observational Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2020
Registry last updated
Jun 29, 2020

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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