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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03501901
Other study ID # UR14-004
Secondary ID
Status Completed
Phase
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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