Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03501901
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2018-04-10
Brief Title:
Urinary Tract Infections Caused by ESBL-producing Enterobacteria
Sponsor:
Universidad Autonoma de Nuevo Leon
Organization:
Universidad Autonoma de Nuevo Leon
Study Overview
Official Title:
Characteristics of Hospital- and Community-acquired Urinary Tract Infections Caused by ESBL-producing Enterobacteria in a Tertiary-care Hospital
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 100000 UFCmL 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
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 100000 UFCmL 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 250000 medical consultations and 22000 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 CFUmL 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 trimethoprimsulfamethoxazole 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 005 Statistical analysis was performed with the SPSS software version 200 IBM Corp Armonk NY
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 100000 UFCmL 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 250000 medical consultations and 22000 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 CFUmL 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 trimethoprimsulfamethoxazole 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 005 Statistical analysis was performed with the SPSS software version 200 IBM Corp Armonk NY
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None