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Urinary Tract Infections Caused by ESBL-producing Enterobacteria

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ClinicalTrials.gov Identifier: NCT03501901
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Hospital Universitario Dr. Jose E. Gonzalez
Information provided by (Responsible Party):
Soraya Mendoza-Olazarán, Universidad Autonoma de Nuevo Leon

Brief 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.

Condition or disease Intervention/treatment
Urinary Tract Infections Diagnostic Test: Antibiotic susceptibility test

Detailed 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).


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Study Type : Observational [Patient Registry]
Actual Enrollment : 353 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Months
Official Title: Characteristics of Hospital- and Community-acquired Urinary Tract Infections Caused by ESBL-producing Enterobacteria in a Tertiary-care Hospital
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : October 31, 2015
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Antibiotic resistance [ Time Frame: 7 month ]
    Antibiotic resistance test were perfomed to all Escherichia coli isolates


Biospecimen Retention:   Samples Without DNA
Strains of enterobacteria


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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:

-


Additional Information:

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Responsible Party: Soraya Mendoza-Olazarán, Clinical Professor, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03501901     History of Changes
Other Study ID Numbers: UR14-004
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Soraya Mendoza-Olazarán, Universidad Autonoma de Nuevo Leon:
ESBL-producing enterobacteria
hospital- and community-acquired urinary tract infections

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents