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

February 27, 2023 updated by: MARINA VALINOTI, Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Ciudad Autonoma De Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1181
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized in an acute tertiary care university teaching hospital in Buenos Aires, Argentina

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRKP infections in CRKP colonized patients
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 3, 2023

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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