NCT05492539

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
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carbapenemase-Producing Enterobacteriaceae

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-05-01
• Completion: 2023-06-03
• First posted: 2022-08-08
• Last updated: 2023-02-28

Locations

1 site across 1 country: Argentina