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

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Recruiting
CT.gov ID
NCT05492539
Collaborator
(none)
500
1
7.1
70.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence and Risk Factors for Developing Infections in Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Feb 3, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Italiano de Buenos Aires Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires Argentina 1181

    Sponsors and Collaborators

    • Hospital Italiano de Buenos Aires

    Investigators

    • Principal Investigator: Marina Valinoti, MD, Hospital Italiano de Buenos Aires

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MARINA VALINOTI, M D, Hospital Italiano de Buenos Aires
    ClinicalTrials.gov Identifier:
    NCT05492539
    Other Study ID Numbers:
    • 3978
    First Posted:
    Aug 8, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MARINA VALINOTI, M D, Hospital Italiano de Buenos Aires
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2022