Clinical trial NCT05492539: Incidence and Risk Factors for Developing Infections in Patients Colonized by CP-KPC
Official title: Incidence and Risk Factors for Developing Infections in Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carbapenemase-Producing Enterobacteriaceae
Keywords: Health Care Associated Infections; Carbapenemase-Producing Enterobacteriaceae; colonization status
Risk Factors
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: CRKP infections in CRKP colonized patients
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: 30 day all-cause mortality
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Ciudad Autonoma De Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Marina Valinoti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giannella M, Trecarichi EM, De Rosa FG, Del Bono V, Bassetti M, Lewis RE, Losito AR, Corcione S, Saffioti C, Bartoletti M, Maiuro G, Cardellino CS, Tedeschi S, Cauda R, Viscoli C, Viale P, Tumbarello M. Risk factors for carbapenem-resistant Klebsiella pneumoniae bloodstream infection among rectal carriers: a prospective observational multicentre study. Clin Microbiol Infect. 2014 Dec;20(12):1357-62. doi: 10.1111/1469-0691.12747. Epub 2014 Aug 11.
citation: Gutierrez-Gutierrez B, Salamanca E, de Cueto M, Hsueh PR, Viale P, Pano-Pardo JR, Venditti M, Tumbarello M, Daikos G, Pintado V, Doi Y, Tuon FF, Karaiskos I, Machuca I, Schwaber MJ, Azap OK, Souli M, Roilides E, Pournaras S, Akova M, Perez F, Bermejo J, Oliver A, Almela M, Lowman W, Almirante B, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J; Investigators from the REIPI/ESGBIS/INCREMENT Group. A Predictive Model of Mortality in Patients With Bloodstream Infections due to Carbapenemase-Producing Enterobacteriaceae. Mayo Clin Proc. 2016 Oct;91(10):1362-1371. doi: 10.1016/j.mayocp.2016.06.024.
citation: Ny P, Nieberg P, Wong-Beringer A. Impact of carbapenem resistance on epidemiology and outcomes of nonbacteremic Klebsiella pneumoniae infections. Am J Infect Control. 2015 Oct 1;43(10):1076-80. doi: 10.1016/j.ajic.2015.06.008. Epub 2015 Jul 17.