- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06542965
Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis
Clinical Characteristics, Risk Factors and Resistance Mechanisms for Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients with P. mirabilis growth in blood culture who met the study criteria were divided into two groups as carbapenem susceptible and resistant according to carbapenem antibiogram results. Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group and patients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group.
Demographic characteristics of the patients, concomitant chronic diseases, Charlson comorbidity index (CCI), hospital and intensive care unit (ICU) hospitalization and number of days in the last year, history and type of invasive intervention in the last three months (surgical-invasive), history of antibiotic use in the last three months and types of antibiotics used (Penicillin, cephalosporin, quinolone, carbapenem, tigecycline, colistin, aminoglycoside), hospitalization unit, total length of hospitalization, sample collection unit, growth result and antibiogram, clinical and laboratory data of the day of growth, sepsis and septic shock evaluated according to systemic inflammatory response syndrome (SIRS) criteria, 30-day mortality and patient outcome information were recorded.
Carbapenemase-producing gene regions were investigated by Polymerase Chain Reaction (PCR) in accessible samples of patients with carbapenem-resistant P. mirabilis growth in blood cultures.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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İzmir, Turkey, 35400
- Dokuz Eylul University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inpatients aged 18 years and older
- P. mirabilis growth in blood cultures
Exclusion Criteria:
- Samples taken in emergency departments, outpatient clinics, day treatment units
- Recurrent growths of the same patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Case (Patients with carbapenem-resistant P. mirabilis)
Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group
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Non-Interventional Research
|
|
Control (Patients with carbapenem- susceptible P. mirabilis)
Patients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group
|
Non-Interventional Research
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Carbapenem Use
Time Frame: 1 year
|
number of patients using carbapenem before P. mirabilis growth in blood cultures
|
1 year
|
|
Intensive Care Units
Time Frame: 1 year
|
number of patients admission in ıntensive care units before P. mirabilis growth in blood cultures
|
1 year
|
|
Mortality
Time Frame: 30 days
|
number of patients who died
|
30 days
|
|
Length of hospital stay
Time Frame: 1 year
|
Length of hospital stay days
|
1 year
|
|
Presence of chronic disease
Time Frame: 1 year
|
number of patients with chronic disease
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Çağlar IRMAK, Dokuz Eylul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEU-INF-IRMAK-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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