Incidence and Risk Factors for Developing Infections in Patients Colonized by CP-KPC

Study Overview
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Brief Summary
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The worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem. Infections caused by carbapenem-resistant Klebsiella pneumoniae (CR-KP) are associated with high morbidity and mortality. Mortality of up to 70% and, in survivors, a readmission rate of up to 72% within 90 days of discharge have been reported. CR-KP infection is usually preceded by colonization. However, the incidence rate and risk factors for CR-KP infections among carriers is poorly understood. Multiple studies have focused in risk factors to develop infections among carriers. In order to identify patients at low risk of CR-KP bloodstream infections, Gianella et at developed a predictive score to stratify patients according to their risk for acquisition of CR-KP infections. However, further studies are needed to validate these results, particularly in high-risk patients, such as haematological patients, solid organ trasplant recipients and patients admitted in ICU. Italian Hospital is an acute tertiary care university teaching hospital with more than 45,000 admission-years, in Buenos Aires, Argentina, with a great proportion of haematological and solid organ transplant recipients, and patients with substantial comorbidities and immunosuppression. With the aim of developing an adequate risk assessment for CR-KP infections among CR-KP carriers, we performed a retrospective cohort analysis, in a tertiary teaching hospital in Buenos Aires, Argentina. The main purpose of our study is to describe the incidence of CR-KP infections among CRKP colonized patients, to demonstrate the risk factors for acquisition of CR-KP infections and to develop a clinical predictive score that could stratify patients to guide therapeutic decisions in CR-KP carriers, and avoid overuse of broad-spectrum therapy.

Official Title
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Incidence and Risk Factors for Developing Infections in Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae

Conditions
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Carbapenemase-Producing Enterobacteriaceae

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized from 01/2014 to 01/2019 Exclusion Criteria: Unwillingness to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRKP infections in CRKP colonized patients | the presence of a positive clinical culture of CR-KP, a documented physician diagnosis, and the initiation of targeted antimicrobial therapy. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day all-cause mortality | 30-day mortality rate starting from the date the relevant clinical culture was obtained. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Care Associated Infections; Carbapenemase-Producing Enterobacteriaceae; colonization status, Risk Factors