Urinary Tract InfectionsNCT03501901
Urinary Tract Infections Caused by ESBL-producing Enterobacteria
An observational study of Urinary Tract Infections, run by Universidad Autonoma de Nuevo Leon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Antibiotic susceptibility test
- How many people
- 353 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 1 Oct 2017
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients (> 18 years old) with a UTI and a positive urine culture (> 100,000 UFC/mL) from March to October 2015 were included
Who cannot join
- -
About this study
Official title: Characteristics of Hospital- and Community-acquired Urinary Tract Infections Caused by ESBL-producing Enterobacteria in a Tertiary-care Hospital
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.
Read the 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).
- Conditions
- Urinary Tract Infections
- Being tested
- Antibiotic susceptibility test
- Keywords
- ESBL-producing enterobacteria, hospital- and community-acquired urinary tract infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic susceptibility testDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic resistance
Antibiotic resistance test were perfomed to all Escherichia coli isolates
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Mar 2015
- Primary completion31 Oct 2015
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Responsible party
- Principal investigator, Soraya Mendoza-Olazarán, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501901
- Sponsor's protocol ID
- UR14-004
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Hospital- and Community-acquired Urinary Tract Infections Caused by ESBL-producing Enterobacteria in a Tertiary-care Hospital
- ClinicalTrials.gov ID
- NCT03501901
- Acronym / sponsor ID
- UR14-004
- Conditions
- Urinary Tract Infections
- Keywords
- ESBL-producing enterobacteria, hospital- and community-acquired urinary tract infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients (> 18 years old) with a UTI and a positive urine culture (> 100,000 UFC/mL) from March to October 2015 were included
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic susceptibility test | Diagnostic test | – |
Primary outcome
Antibiotic resistance
Time frame: 7 month
Antibiotic resistance test were perfomed to all Escherichia coli isolates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Universidad Autonoma de Nuevo Leon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic resistance (time frame: 7 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.