Antimicrobial ResistanceNCT06305455
Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship
An observational study of Antimicrobial Resistance, run by José Raimundo Araujo de Azevedo.
Trial summary
The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Resistance
- What is being tested?
- Escherichia coli ESBL
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Oct 2024
- 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: Adult patients with severe Escherichia coli infections, isolated from any culture material collected within less than 48 hours of hospital admission, admitted to the intensive care unit of a tertiary hospital.
Who may be able to join
- All 18 years and old patients admitted to the ICU
- Positive cultures for E. coli
- Any sample collected within 48 hours of hospital admission
Who cannot join
- Lack of necessary data
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Change in the Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship
The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit.
Read the detailed description
Background: The growing antimicrobial resistance in bacterial pathogens represents a severe public health problem. Isolation of Escherichia coli ESBL has been identified more frequently over the years due to the worldwide dissemination of strains with this phenotypic profile. The ICU has a fully functioning Antimicrobial Stewardship team, with data managed daily. Thus, the investigators identified increasing E. coli ESBL isolates resistant to standard empiric antimicrobial therapy in community-based severe infections.
Purpose: The choice of empirical antimicrobial therapy is an increasingly present challenge in clinical practice, often determining the outcome of critically ill patients. As this is a highly relevant topic in managing this patient profile, antimicrobial stewardship protocols are essential in health services, enabling continuous community monitoring of emerging resistance profiles. The justification for this study is based on the possibility of adding knowledge on the topic, aiming to add to the global theoretical collection and alert about the locoregional occurrence of changes in the bacterial resistance profile.
Objectives: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the ICU.
- Conditions
- Antimicrobial Resistance
- Being tested
- Escherichia coli ESBL
- Keywords
- antimicrobial resistance, Escherichia coli ESBL, antimicrobial stewardship, community infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escherichia coli ESBLBiological
To evaluate the change in the resistance profile of infections of community origin caused by Escherichia coli, isolated from any culture material in patients admitted to the intensive care unit of a tertiary hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Escherichia coli resistance
The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community admitted to the ICU.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial ResistanceStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- José Raimundo Araujo de Azevedo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- RODRIGO AZEVEDO, MD, PhD, Study director, Hospital São Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305455
- Sponsor's protocol ID
- HSD135
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisenreich W, Rudel T, Heesemann J, Goebel W. Link Between Antibiotic Persistence and Antibiotic Resistance in Bacterial Pathogens. Front Cell Infect Microbiol. 2022 Jul 19;12:900848. doi: 10.3389/fcimb.2022.900848. eCollection 2022.
PubMed 35928205Zhu DM, Li QH, Shen Y, Zhang Q. Risk factors for quinolone-resistant Escherichia coli infection: a systematic review and meta-analysis. Antimicrob Resist Infect Control. 2020 Jan 9;9(1):11. doi: 10.1186/s13756-019-0675-3. eCollection 2020.
PubMed 31938541Castanheira M, Deshpande LM, Mendes RE, Canton R, Sader HS, Jones RN. Variations in the Occurrence of Resistance Phenotypes and Carbapenemase Genes Among Enterobacteriaceae Isolates in 20 Years of the SENTRY Antimicrobial Surveillance Program. Open Forum Infect Dis. 2019 Mar 15;6(Suppl 1):S23-S33. doi: 10.1093/ofid/ofy347. eCollection 2019 Mar.
PubMed 30895212Canton R, Gijon D, Ruiz-Garbajosa P. Antimicrobial resistance in ICUs: an update in the light of the COVID-19 pandemic. Curr Opin Crit Care. 2020 Oct;26(5):433-441. doi: 10.1097/MCC.0000000000000755.
PubMed 32739970Kim JY, Yum Y, Joo HJ, An H, Yoon YK, Kim JH, Sohn JW. Impact of antibiotic usage on extended-spectrum beta-lactamase producing Escherichia coli prevalence. Sci Rep. 2021 Jun 22;11(1):13024. doi: 10.1038/s41598-021-91332-x.
PubMed 34158540
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in the Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship
- ClinicalTrials.gov ID
- NCT06305455
- Acronym / sponsor ID
- HSD135
- Conditions
- Antimicrobial Resistance
- Keywords
- antimicrobial resistance, Escherichia coli ESBL, antimicrobial stewardship, community infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- José Raimundo Araujo de AzevedoUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Mar 2024 (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 main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit.
Detailed description
Background: The growing antimicrobial resistance in bacterial pathogens represents a severe public health problem. Isolation of Escherichia coli ESBL has been identified more frequently over the years due to the worldwide dissemination of strains with this phenotypic profile. The ICU has a fully functioning Antimicrobial Stewardship team, with data managed daily. Thus, the investigators identified increasing E. coli ESBL isolates resistant to standard empiric antimicrobial therapy in community-based severe infections.
Purpose: The choice of empirical antimicrobial therapy is an increasingly present challenge in clinical practice, often determining the outcome of critically ill patients. As this is a highly relevant topic in managing this patient profile, antimicrobial stewardship protocols are essential in health services, enabling continuous community monitoring of emerging resistance profiles. The justification for this study is based on the possibility of adding knowledge on the topic, aiming to add to the global theoretical collection and alert about the locoregional occurrence of changes in the bacterial resistance profile.
Objectives: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the ICU.
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
- Adult patients with severe Escherichia coli infections, isolated from any culture material collected within less than 48 hours of hospital admission, admitted to the intensive care unit of a tertiary hospital.
Key inclusion criteria (3 listed)
- All 18 years and old patients admitted to the ICU
- Positive cultures for E. coli
- Any sample collected within 48 hours of hospital admission
Key exclusion criteria (1 listed)
- Lack of necessary data
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 |
|---|---|---|
| Escherichia coli ESBLTo evaluate the change in the resistance profile of infections of community origin caused by Escherichia coli, isolated from any culture material in patients admitted to the intensive care unit of a tertiary hospital. | Biological | – |
Primary outcome
Prevalence of Escherichia coli resistance
Time frame: 24 months
The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community admitted to the ICU.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 35928205Eisenreich W, Rudel T, Heesemann J, Goebel W. Link Between Antibiotic Persistence and Antibiotic Resistance in Bacterial Pathogens. Front Cell Infect Microbiol. 2022 Jul 19;12:900848. doi: 10.3389/fcimb.2022.900848. eCollection 2022.
- Results publication: PubMed 31938541Zhu DM, Li QH, Shen Y, Zhang Q. Risk factors for quinolone-resistant Escherichia coli infection: a systematic review and meta-analysis. Antimicrob Resist Infect Control. 2020 Jan 9;9(1):11. doi: 10.1186/s13756-019-0675-3. eCollection 2020.
- Results publication: PubMed 30895212Castanheira M, Deshpande LM, Mendes RE, Canton R, Sader HS, Jones RN. Variations in the Occurrence of Resistance Phenotypes and Carbapenemase Genes Among Enterobacteriaceae Isolates in 20 Years of the SENTRY Antimicrobial Surveillance Program. Open Forum Infect Dis. 2019 Mar 15;6(Suppl 1):S23-S33. doi: 10.1093/ofid/ofy347. eCollection 2019 Mar.
- Results publication: PubMed 32739970Canton R, Gijon D, Ruiz-Garbajosa P. Antimicrobial resistance in ICUs: an update in the light of the COVID-19 pandemic. Curr Opin Crit Care. 2020 Oct;26(5):433-441. doi: 10.1097/MCC.0000000000000755.
- Results publication: PubMed 34158540Kim JY, Yum Y, Joo HJ, An H, Yoon YK, Kim JH, Sohn JW. Impact of antibiotic usage on extended-spectrum beta-lactamase producing Escherichia coli prevalence. Sci Rep. 2021 Jun 22;11(1):13024. doi: 10.1038/s41598-021-91332-x.
- 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.
RODRIGO AZEVEDO, MD, PhD study director
Hospital São Domingos
Questions about this trial
What is this clinical trial studying?
An observational study of Antimicrobial Resistance, run by José Raimundo Araujo de Azevedo.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RODRIGO AZEVEDO, MD, PhD (+55 98 991920321, rpdeazevedo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Escherichia coli resistance (time frame: 24 months). 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 NCT06305455, which also lists 5 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 12 Mar 2024.