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

Recruiting

• Conditions: Carbapenemase-Producing Enterobacteriaceae

• Registration Number: NCT05492539
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
30 day all-cause mortality	through study completion, an average of 1 year	30-day mortality rate starting from the date the relevant clinical culture was obtained.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina