Bloodstream InfectionsNCT07172932
ANTIBIOTIC-RESISTANT ENTEROBACTERALES BLOODSTREAM INFECTIONS AND RISK FACTORS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT
An observational study of Bloodstream Infections and Enterobacteriaceae Infections, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infections, Enterobacteriaceae Infections, Intensive Care (ICU)
- How many people
- 314 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study included adult patients who were hospitalized in the intensive care units (ICUs) of the Neurology-Orthopedics Building at Ankara City Hospital between September 2019 and December 2022. Eligible participants were aged 18 years or older and had a blood culture positive for Enterobacterales species during ICU stay, which was evaluated by an Infectious Diseases and Clinical Microbiology specialist as the causative pathogen.
Who may be able to join
- 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
Who cannot join
- Isolates not considered as causative pathogens
- Growth of a different pathogen in blood culture within ±72 hours of the index culture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Çankaya, Ankara, 06800
About this study
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.
Read the 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.
- Conditions
- Bloodstream Infections, Enterobacteriaceae Infections, Intensive Care (ICU), Antibiotic Resistant Infection
- Keywords
- Bloodstream Infections, esbl, carbapenem resistance, colistin resistance
- Medical subject headings
- Sepsis, Enterobacteriaceae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antibiotic resistance phenotypes (ESBL, carbapenem, colistin) among Enterobacterales bloodstream infection isolates.
Prevalence of antibiotic resistance phenotypes (ESBL, carbapenem, colistin) among Enterobacterales bloodstream infection isolates.
Measured: From January 2019 to December 2022
Secondary outcomes (1)
Identification of patient-related and clinical risk factors associated with antibiotic-resistant Enterobacterales bloodstream infections.
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.
Measured: 2019-2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Sep 2019
- Primary completion30 Sep 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahriye Melis Gürsoy Kurtoğlu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172932
- Sponsor's protocol ID
- E1-21-2215
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTIBIOTIC-RESISTANT ENTEROBACTERALES BLOODSTREAM INFECTIONS AND RISK FACTORS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT
- ClinicalTrials.gov ID
- NCT07172932
- Acronym / sponsor ID
- E1-21-2215
- Conditions
- Bloodstream Infections, Enterobacteriaceae Infections, Intensive Care (ICU), Antibiotic Resistant Infection
- Keywords
- Bloodstream Infections, esbl, carbapenem resistance, colistin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included adult patients who were hospitalized in the intensive care units (ICUs) of the Neurology-Orthopedics Building at Ankara City Hospital between September 2019 and December 2022. Eligible participants were aged 18 years or older and had a blood culture positive for Enterobacterales species during ICU stay, which was evaluated by an Infectious Diseases and Clinical Microbiology specialist as the causative pathogen.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Isolates not considered as causative pathogens
- Growth of a different pathogen in blood culture within ±72 hours of the index culture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of antibiotic resistance phenotypes (ESBL, carbapenem, colistin) among Enterobacterales bloodstream infection isolates.
Time frame: From January 2019 to December 2022
Prevalence of antibiotic resistance phenotypes (ESBL, carbapenem, colistin) among Enterobacterales bloodstream infection isolates.
1 secondary outcome
Identification of patient-related and clinical risk factors associated with antibiotic-resistant Enterobacterales bloodstream infections.
Time frame: 2019-2022.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infections and Enterobacteriaceae Infections, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of antibiotic resistance phenotypes (ESBL, carbapenem, colistin) among Enterobacterales bloodstream infection isolates. (time frame: From January 2019 to December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.