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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05492539

Acronym

KPC

Enrollment

500

Registered

2022-08-08

Start date

2022-07-01

Completion date

2023-06-03

Last updated

2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbapenemase-Producing Enterobacteriaceae

Keywords

Health Care Associated Infections; Carbapenemase-Producing Enterobacteriaceae; colonization status, Risk Factors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Argentina

Contacts

Primary ContactMarina Valinoti, MD

marina.valinoti@hiba.org.ar+541166631624

Backup ContactDiego Giunta, PhD, MD

diego.giunta@hiba.org.ar+54 49590200

Outcome results