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Compliance of Initial Empiric Antimicrobial Therapy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04448665
Enrollment
267
Registered
2020-06-26
Start date
2018-02-01
Completion date
2020-02-15
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Infective Agents

Keywords

empirical therapy, antimicrobial agents, hospital infections

Brief summary

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).

Interventions

DIAGNOSTIC_TESTmicrobiological investigation

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

Sponsors

Military Institute od Medicine National Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of initial empiric therapyImmediately after the completion of microbiological analysesThe comparison of initially administered antimicrobial agent with the results of microbiological analyses (susceptibility/resistance of the isolated pathogen).

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026