Urinary Tract Infections Caused by ESBL-producing Enterobacteria

Urinary Tract Infections Clinical Trial

Official title:

Characteristics of Hospital- and Community-acquired Urinary Tract Infections Caused by ESBL-producing Enterobacteria in a Tertiary-care Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501901
• Other study ID #: UR14-004
• Status: Completed
• First received: April 10, 2018
• Last updated: April 17, 2018
• Start date: March 1, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: April 2018
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study was to compare the etiologic agents, the antimicrobial resistance rates, and the risk factors associated with a HA-UTI and CA-UTI among complicated and uncomplicated UTI patients in a tertiary-care hospital in Mexico. This study was performed according to the principles expressed in the Declaration of Helsinki with the approval of the Local Ethics Committee of the School of Medicine of the Universidad Autónoma de Nuevo León (UR14-004). All patients with a UTI and a positive urine culture (> 100,000 UFC/mL) from March to October 2015 were included. The study was carried out at the Hospital Universitario "Dr. José Eleuterio González" hospital, a tertiary-care teaching hospital in Monterrey, Mexico. Identification and susceptibility antibiotic assays were performed to all isolates from positive urine culture.

Description:

The aim of this study was to compare the etiologic agents, the antimicrobial resistance rates, and the risk factors associated with a HA-UTI and CA-UTI among complicated and uncomplicated UTI patients in a tertiary-care hospital in Mexico.

This study was performed according to the principles expressed in the Declaration of Helsinki with the approval of the Local Ethics Committee of the School of Medicine of the Universidad Autónoma de Nuevo León (UR14-004).

All patients with a UTI and a positive urine culture (> 100,000 UFC/mL) from March to October 2015 were included. The study was carried out at the Hospital Universitario "Dr. José Eleuterio González" hospital, a tertiary-care teaching hospital in Monterrey, Mexico. This hospital has 500 beds, serves a population of approximately 5 million people, and has an average of 250,000 medical consultations and 22,000 hospitalizations annually.

A UTI was defined as the presence of symptoms related to the urinary tract, pyuria (≥10 leucocytes per high-power field) and a positive urine culture (≥105 CFU/mL) of one uropathogen according to the guidelines of the Infectious Diseases Society of America (IDSA) and the European Association of Urology (EAU). Patients with urine cultures with significative counts of two or more bacterial species were excluded.

Patients' charts were reviewed for clinical and demographic characteristics. The classification of UTIs as either complicated or uncomplicated, and hospital-acquired or community-acquired, was based on the IDSA and EAU criteria. Cases which could not be classified due to insufficient clinical information were excluded.

Urine cultures were performed according to standard protocols. Species identification of all isolates was performed using MALDI-TOF mass spectrometry (Microflex, Bruker Daltonics, Billerica, MA). The drug resistance profile of all E. coli isolates was determined using the broth microdilution method for gentamicin, amoxicillin-clavulanic acid, aztreonam, ceftriaxone, ertapenem, ciprofloxacin, levofloxacin, nitrofurantoin, trimethoprim/sulfamethoxazole, and colistin; except fosfomycin, in which the agar dilution method was used. The results were interpreted according to the Clinical and Laboratory Standards Institute (CLSI) criteria.

Multidrug resistance (MDR) was defined as non-susceptibility to at least one agent in three or more antimicrobial categories. All isolates with resistance to at least one third-generation cephalosporin were evaluated for production of ESBL in E. coli using the double-disc test according to the CLSI.

Categorical variables were expressed as frequencies and percentages. Numerical variables were expressed as a mean and standard deviation. Clinical and demographic characteristics were analyzed using the χ2 test for categorical variables and the t-test (or Mann-Whitney test in the absence of normal distribution) for continuous variables. Statistical significance was set at p <0.05. Statistical analysis was performed with the SPSS software version 20.0 (IBM Corp, Armonk, NY).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: October 1, 2017
• Est. primary completion date: October 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients (> 18 years old) with a UTI and a positive urine culture (> 100,000 UFC/mL) from March to October 2015 were included

Exclusion Criteria:

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Diagnostic Test:
• Antibiotic susceptibility test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon	Hospital Universitario Dr. Jose E. Gonzalez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic resistance	Antibiotic resistance test were perfomed to all Escherichia coli isolates	7 month