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ANTIBIOTIC-RESISTANT ENTEROBACTERALES BLOODSTREAM INFECTIONS AND RISK FACTORS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT

ANTIBIOTIC-RESISTANT ENTEROBACTERALES BLOODSTREAM INFECTIONS AND RISK FACTORS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07172932
Enrollment
314
Registered
2025-09-15
Start date
2019-09-01
Completion date
2023-01-30
Last updated
2025-09-15

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

Conditions

Antibiotic Resistant Infection, Bloodstream Infections, Enterobacteriaceae Infections, Intensive Care (ICU)

Keywords

Bloodstream Infections, esbl, carbapenem resistance, colistin resistance

Brief summary

In this study, we first aimed to reveal the resistance profile of Enterobacteriales bloodstream infections at our center. We evaluated data from patients with ESBL, colistin, and carbapenem resistance and identified resistance risk factors. We then reviewed our approach to managing the infection based on the results obtained.Patients were grouped according to resistance patterns and resistance status and compared retrospectively.

Detailed description

Antibiotic resistance represents one of the most urgent and serious challenges confronting modern healthcare systems. This problem is particularly critical in intensive care units (ICUs), where bloodstream infections (BSIs) caused by resistant organisms are frequently associated with prolonged hospitalization, increased healthcare costs, therapeutic failures, and high mortality rates. Over the past decade, the incidence of bloodstream infections due to Enterobacterales species has risen substantially worldwide. These pathogens possess diverse resistance mechanisms that undermine the effectiveness of commonly used antibiotics. Among the most clinically significant are extended-spectrum beta-lactamases (ESBLs), carbapenemase production, and the emergence of colistin resistance phenotypes. These mechanisms not only limit empiric treatment options but also complicate infection control practices and contribute to the spread of multidrug-resistant organisms across healthcare facilities. In Turkey, national and multicenter surveillance data indicate that resistance rates among ICU isolates of Klebsiella pneumoniae and Escherichia coli often exceed the European average. This situation directly impacts empiric antibiotic therapy by reducing the likelihood of initial treatment success, while also facilitating the nosocomial transmission of resistant strains. Consequently, optimizing empiric therapy strategies and strengthening infection control measures are of paramount importance in ICUs. The present study was designed to retrospectively evaluate all cases of Enterobacterales bloodstream infections (EBSIs) diagnosed in our center between 2019 and 2022. The primary objectives were: To identify the prevalence and distribution of key antibiotic resistance phenotypes (including ESBL, carbapenem, and colistin resistance). To analyze patient- and treatment-related risk factors associated with the emergence of resistance. To assess the potential clinical consequences of resistance in terms of morbidity, mortality, and therapeutic outcomes. To provide evidence-based data that may inform and support the development of local infection control policies and antimicrobial stewardship interventions. By systematically examining the resistance patterns and associated risk factors in a large cohort of ICU patients, this study aims to contribute to a better understanding of the epidemiology of resistant Enterobacterales infections. Furthermore, the findings are expected to provide valuable insights for revising empiric treatment guidelines and for guiding infection control strategies tailored to high-risk patient populations.

Interventions

None listed

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

* Age ≥ 18 years * Isolation of an Enterobacterales species from a blood culture obtained during ICU stay * The isolate considered as the causative pathogen by an Infectious Diseases and Clinical Microbiology specialist

Exclusion criteria

* Isolates not considered as causative pathogens * Growth of a different pathogen in blood culture within ±72 hours of the index culture

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of antibiotic resistance phenotypes (ESBL, carbapenem, colistin) among Enterobacterales bloodstream infection isolates.From January 2019 to December 2022Prevalence of antibiotic resistance phenotypes (ESBL, carbapenem, colistin) among Enterobacterales bloodstream infection isolates.

Secondary

MeasureTime frameDescription
Identification of patient-related and clinical risk factors associated with antibiotic-resistant Enterobacterales bloodstream infections.2019-2022.Risk factors such as age, comorbidities, prior antibiotic use, invasive device utilization (mechanical ventilation, central venous catheter, urinary catheter), and ICU stay will be analyzed.

Countries

Turkey (Türkiye)

Outcome results

None listed

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