Clinical trial NCT06305455: Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship
Official title: Change in the Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Antimicrobial Resistance
Keywords: antimicrobial resistance
Escherichia coli ESBL
antimicrobial stewardship
community infections
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with severe Escherichia coli infections, isolated from any culture material collected within less than 48 hours of hospital admission, admitted to the intensive care unit of a tertiary hospital.

Brief summary: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit.

Detailed description: Background: The growing antimicrobial resistance in bacterial pathogens represents a severe public health problem. Isolation of Escherichia coli ESBL has been identified more frequently over the years due to the worldwide dissemination of strains with this phenotypic profile. The ICU has a fully functioning Antimicrobial Stewardship team, with data managed daily. Thus, the investigators identified increasing E. coli ESBL isolates resistant to standard empiric antimicrobial therapy in community-based severe infections.

Purpose: The choice of empirical antimicrobial therapy is an increasingly present challenge in clinical practice, often determining the outcome of critically ill patients. As this is a highly relevant topic in managing this patient profile, antimicrobial stewardship protocols are essential in health services, enabling continuous community monitoring of emerging resistance profiles. The justification for this study is based on the possibility of adding knowledge on the topic, aiming to add to the global theoretical collection and alert about the locoregional occurrence of changes in the bacterial resistance profile.

Objectives: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the ICU.

Eligibility criteria: Inclusion Criteria:

* All 18 years and old patients admitted to the ICU
* Positive cultures for E. coli
* Any sample collected within 48 hours of hospital admission

Exclusion Criteria:

* Lack of necessary data

Primary outcomes:
measure: Prevalence of Escherichia coli resistance
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital São Domingos
name: RODRIGO AZEVEDO, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Eisenreich W, Rudel T, Heesemann J, Goebel W. Link Between Antibiotic Persistence and Antibiotic Resistance in Bacterial Pathogens. Front Cell Infect Microbiol. 2022 Jul 19;12:900848. doi: 10.3389/fcimb.2022.900848. eCollection 2022.
citation: Zhu DM, Li QH, Shen Y, Zhang Q. Risk factors for quinolone-resistant Escherichia coli infection: a systematic review and meta-analysis. Antimicrob Resist Infect Control. 2020 Jan 9;9(1):11. doi: 10.1186/s13756-019-0675-3. eCollection 2020.
citation: Castanheira M, Deshpande LM, Mendes RE, Canton R, Sader HS, Jones RN. Variations in the Occurrence of Resistance Phenotypes and Carbapenemase Genes Among Enterobacteriaceae Isolates in 20 Years of the SENTRY Antimicrobial Surveillance Program. Open Forum Infect Dis. 2019 Mar 15;6(Suppl 1):S23-S33. doi: 10.1093/ofid/ofy347. eCollection 2019 Mar.
citation: Canton R, Gijon D, Ruiz-Garbajosa P. Antimicrobial resistance in ICUs: an update in the light of the COVID-19 pandemic. Curr Opin Crit Care. 2020 Oct;26(5):433-441. doi: 10.1097/MCC.0000000000000755.
citation: Kim JY, Yum Y, Joo HJ, An H, Yoon YK, Kim JH, Sohn JW. Impact of antibiotic usage on extended-spectrum beta-lactamase producing Escherichia coli prevalence. Sci Rep. 2021 Jun 22;11(1):13024. doi: 10.1038/s41598-021-91332-x.