NCT06305455

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 5, 2024

Last Update Submit

March 10, 2024

Conditions

Keywords

antimicrobial resistanceEscherichia coli ESBLantimicrobial stewardshipcommunity infections

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Lack of necessary data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • RODRIGO AZEVEDO, MD, PhD

    Hospital São Domingos

    STUDY DIRECTOR

Central Study Contacts

RODRIGO AZEVEDO, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

April 1, 2024

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share