Urinary Tract InfectionsNCT04616352
Cefuroxime Resistance in Pyelonephritis
An observational study of Urinary Tract Infections, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
Resistance to empirical antibiotic treatment has resulted in increased mortality and morbidity in serious infections caused by certain common resistant pathogens in the community. 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?
- Resistance to cefuroxime
- How many people
- 973 participants
- Where
- 1 siteColombia
- Study dates
- 26 Dec 2020to 30 Jul 2021
- 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: Patiens with ≥ 18 years with a clinical diagnosis of community acquired pyelonephritis that require hospitalization and with positive culture for Escherichia coli.
Who may be able to join
- Age ≥ 18 years.
- Clinical diagnosis of pyelonephritis.
- Antibiotic treatment with cefuroxime.
- Urine culture positive for Escherichia coli
Who cannot join
- Use of antibiotic for less than 24 hours.
- Not availability of antimicrobial susceptibility testing.
- Use of urinary catheter for more than 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inappropriate Therapy With Cefuroxime in Adult Patients Hospitalized With Pyelonephritis
Resistance to empirical antibiotic treatment has resulted in increased mortality and morbidity in serious infections caused by certain common resistant pathogens in the community. The risk for increased mortality has been also the motivation for recent guidelines that suggest early empirical antimicrobial treatment with broad spectrum antibiotics within a few hours of suspecting sepsis, regardless of the potential microorganism or infection focus. Resistance to second-generation cephalosporins among patients with community-acquired urinary tract infection by E. coli has exceeded 20% in an increasing number of institutions and communities, without being clear about the impact of such resistance on the effectiveness of treatment. This is especially important in urinary infections, since, in general, mortality is very low. We expect to establish if there is a relationship between inappropriate empirical therapy and morbidity (in terms of length of stay or readmission) among hospitalized patients with pyelonephritis treated with empirical cefuroxime therapy to help to define the need for a change in the current guidelines. These guidelines will have application not only in Colombia, but also in other countries in Latin America or other countries that still use this empirical therapy. It will also define the need for use of broader spectrum antibiotics in this clinical scenario.
Read the detailed description
Objectives:
- Establish the relationship between inappropriate empirical cefuroxime therapy in adult patients hospitalized with pyelonephritis and hospital stay.
- Establish the relationship between inappropriate empirical cefuroxime therapy in adult patients hospitalized with pyelonephritis and readmission due to pyelonephritis.
- Establish the relationship between inappropriate empirical therapy with cefuroxime in adult patients hospitalized with pyelonephritis and the time to readmission caused pyelonephritis.
The investigators proposed a retrospective cohort of hospitalized pyelonephritis patients with empirical antimicrobial management with cefuroxime in one institution of third complexity level. Exposure is understood as resistance to cefuroxime, that is, the impact of inappropriate empirical cefuroxime therapy on patients receiving this antibiotic. Patients who are admitted to the cohort had the diagnosis of pyelonephritis and were hospitalized for intravenous antimicrobial treatment and are followed up to the following outcomes: hospital discharge, or readmission due to pyelonephritis to the same or another institution of the insurance network.
The study will be conducted following the Good Clinical Practices for Research and approval by the Research Ethics Committee (REC) or Investigation Research Boards (IRB) of the participating institutions. The clinical information will be collected through online forms based on the information in the electronic medical record. Microbiological information will be taken from clinical laboratory reports (Whonet ver 5.5., WHO). The accuracy of the information collected will be verified by evaluating 100% of the formats. A pilot test will be carried out after approval by the IRB (25 february, 2020). The information will be stored anonymously, discarding from the database personal information of the patient that might allow the identification. Variables collected from the Electronic Medical Record include demographic, clinical (comorbidities, clinical status) and microbiological information. Other variables include time to change antibiotic (if done) and time of use of antibiotic. Information for the outcomes proposed include length of stay (in days), readmission (new admission because of pyelonephritis in the following 30 days after the first episode), and time to readmission (in days).
A propensity score matching will be performed to diminish the risk of selection bias and unbalanced subjects. Alternatively, and inverse probability treatment weighting can be used to balance the variables included. Both models will be constructed using a logistic regression for the probability of cefuroxime resistant. Final comparison between the exposed population and control population will be done using survival curves for the time to hospital discharge.
- Conditions
- Urinary Tract Infections
- Being tested
- Resistance to cefuroxime
- Keywords
- pyelonephritis, urinary tract infections, complicated, cefuroxime, cephalosporins, Escherichia coli, Drug Resistance, Microbial
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance to cefuroximeOther
Non susceptibility in vitro testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hospital discharge
Time since admission to hospital discharge
Measured: Up to 30 days
Readmission
Proportion of patients admitted to hospital because of new episode of urinary tract infection
Measured: Up to 30 days after discharge
Time to readmission
Time since discharge to readmission
Measured: Up to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start26 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Alberto Cortes Luna, Universidad Nacional de Colombia
- Investigators
- Jorge A Cortes, MD, Principal investigator, Univesidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616352
- Sponsor's protocol ID
- ivucef001
- Status last verified
- Aug 2021
- First submitted
- 18 Oct 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nocua-Baez LC, Cortes JA, Leal AL, Arias GF, Ovalle-Guerro MV, Saavedra-Rojas SY, Buitrago G, Escobar-Perez JA, Castro-Cardozo B. [Antimicrobial susceptibility profile in urinary pathogens causing community-acquired infections in diabetic patients in Colombia]. Biomedica. 2017 Sep 1;37(3):353-360. doi: 10.7705/biomedica.v37i3.3348. Spanish.
PubMed 28968012Leal AL, Cortes JA, Arias G, Ovalle MV, Saavedra SY, Buitrago G, Escobar JA, Castro BE; GREBO. [Emergence of resistance to third generation cephalosporins by Enterobacteriaceae causing community-onset urinary tract infections in hospitals in Colombia]. Enferm Infecc Microbiol Clin. 2013 May;31(5):298-303. doi: 10.1016/j.eimc.2012.04.007. Epub 2012 Jun 15. Spanish.
PubMed 22703702
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inappropriate Therapy With Cefuroxime in Adult Patients Hospitalized With Pyelonephritis
- ClinicalTrials.gov ID
- NCT04616352
- Acronym / sponsor ID
- ivucef001
- Conditions
- Urinary Tract Infections
- Keywords
- pyelonephritis, urinary tract infections, complicated, cefuroxime, cephalosporins, Escherichia coli, Drug Resistance, Microbial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 26 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 4 Nov 2020 (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.
Resistance to empirical antibiotic treatment has resulted in increased mortality and morbidity in serious infections caused by certain common resistant pathogens in the community. The risk for increased mortality has been also the motivation for recent guidelines that suggest early empirical antimicrobial treatment with broad spectrum antibiotics within a few hours of suspecting sepsis, regardless of the potential microorganism or infection focus. Resistance to second-generation cephalosporins among patients with community-acquired urinary tract infection by E. coli has exceeded 20% in an increasing number of institutions and communities, without being clear about the impact of such resistance on the effectiveness of treatment. This is especially important in urinary infections, since, in general, mortality is very low. We expect to establish if there is a relationship between inappropriate empirical therapy and morbidity (in terms of length of stay or readmission) among hospitalized patients with pyelonephritis treated with empirical cefuroxime therapy to help to define the need for a change in the current guidelines. These guidelines will have application not only in Colombia, but also in other countries in Latin America or other countries that still use this empirical therapy. It will also define the need for use of broader spectrum antibiotics in this clinical scenario.
Detailed description
Objectives:
- Establish the relationship between inappropriate empirical cefuroxime therapy in adult patients hospitalized with pyelonephritis and hospital stay.
- Establish the relationship between inappropriate empirical cefuroxime therapy in adult patients hospitalized with pyelonephritis and readmission due to pyelonephritis.
- Establish the relationship between inappropriate empirical therapy with cefuroxime in adult patients hospitalized with pyelonephritis and the time to readmission caused pyelonephritis.
The investigators proposed a retrospective cohort of hospitalized pyelonephritis patients with empirical antimicrobial management with cefuroxime in one institution of third complexity level. Exposure is understood as resistance to cefuroxime, that is, the impact of inappropriate empirical cefuroxime therapy on patients receiving this antibiotic. Patients who are admitted to the cohort had the diagnosis of pyelonephritis and were hospitalized for intravenous antimicrobial treatment and are followed up to the following outcomes: hospital discharge, or readmission due to pyelonephritis to the same or another institution of the insurance network.
The study will be conducted following the Good Clinical Practices for Research and approval by the Research Ethics Committee (REC) or Investigation Research Boards (IRB) of the participating institutions. The clinical information will be collected through online forms based on the information in the electronic medical record. Microbiological information will be taken from clinical laboratory reports (Whonet ver 5.5., WHO). The accuracy of the information collected will be verified by evaluating 100% of the formats. A pilot test will be carried out after approval by the IRB (25 february, 2020). The information will be stored anonymously, discarding from the database personal information of the patient that might allow the identification. Variables collected from the Electronic Medical Record include demographic, clinical (comorbidities, clinical status) and microbiological information. Other variables include time to change antibiotic (if done) and time of use of antibiotic. Information for the outcomes proposed include length of stay (in days), readmission (new admission because of pyelonephritis in the following 30 days after the first episode), and time to readmission (in days).
A propensity score matching will be performed to diminish the risk of selection bias and unbalanced subjects. Alternatively, and inverse probability treatment weighting can be used to balance the variables included. Both models will be constructed using a logistic regression for the probability of cefuroxime resistant. Final comparison between the exposed population and control population will be done using survival curves for the time to hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patiens with ≥ 18 years with a clinical diagnosis of community acquired pyelonephritis that require hospitalization and with positive culture for Escherichia coli.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Clinical diagnosis of pyelonephritis.
- Antibiotic treatment with cefuroxime.
- Urine culture positive for Escherichia coli
Key exclusion criteria (3 listed)
- Use of antibiotic for less than 24 hours.
- Not availability of antimicrobial susceptibility testing.
- Use of urinary catheter for more than 30 days.
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 |
|---|---|---|
| Resistance to cefuroximeNon susceptibility in vitro testing | Other | – |
Primary outcome
Time to hospital discharge
Time frame: Up to 30 days
Time since admission to hospital discharge
Readmission
Time frame: Up to 30 days after discharge
Proportion of patients admitted to hospital because of new episode of urinary tract infection
Time to readmission
Time frame: Up to 30 days after discharge
Time since discharge to readmission
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 3 Aug 2021.
- Background: PubMed 28968012Nocua-Baez LC, Cortes JA, Leal AL, Arias GF, Ovalle-Guerro MV, Saavedra-Rojas SY, Buitrago G, Escobar-Perez JA, Castro-Cardozo B. [Antimicrobial susceptibility profile in urinary pathogens causing community-acquired infections in diabetic patients in Colombia]. Biomedica. 2017 Sep 1;37(3):353-360. doi: 10.7705/biomedica.v37i3.3348. Spanish.
- Background: PubMed 22703702Leal AL, Cortes JA, Arias G, Ovalle MV, Saavedra SY, Buitrago G, Escobar JA, Castro BE; GREBO. [Emergence of resistance to third generation cephalosporins by Enterobacteriaceae causing community-onset urinary tract infections in hospitals in Colombia]. Enferm Infecc Microbiol Clin. 2013 May;31(5):298-303. doi: 10.1016/j.eimc.2012.04.007. Epub 2012 Jun 15. Spanish.
- Individual participant dataSharing planned: No
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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.
Jorge A Cortes, MD principal investigator
Univesidad Nacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 4 inclusion and 3 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Time to hospital discharge (time frame: Up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616352, which also lists 2 linked publications.
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 3 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.