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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06305455
Other study ID # HSD135
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date October 2024

Study information

Verified date March 2024
Source Hospital Sao Domingos
Contact RODRIGO AZEVEDO, MD, PhD
Phone +55 98 991920321
Email rpdeazevedo@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
Escherichia coli ESBL
To evaluate the change in the resistance profile of infections of community origin caused by Escherichia coli, isolated from any culture material in patients admitted to the intensive care unit of a tertiary hospital.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
José Raimundo Araujo de Azevedo

References & Publications (5)

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. — View 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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Escherichia coli resistance The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community admitted to the ICU. 24 months
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