Compliance of Initial Empiric Antimicrobial Therapy

NCT04448665 | Completed

• 1 other identifier: 681006-08
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

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).

Conditions

Anti-Infective Agents

Keywords

empirical therapy; antimicrobial agents; hospital infections

Outcome Measures

Primary Outcomes (1)

• Accuracy of initial empiric therapy

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

  Immediately after the completion of microbiological analyses

Study Arms (1)

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.

Diagnostic Test: microbiological investigation

Interventions

microbiological investigation DIAGNOSTIC_TEST

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

patients with suspected infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Due to study design we performed no descriptive analyses of the study population.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Department of Anesthesiology and Intensive Therapy

Warsaw, 04-141, Poland

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dariusz Tomaszewski, MD, PhD

  Department of Anesthesiology and Intensive Therapy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: February 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 15, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

PL (1)