ESBL-producing Enterobacteriaceae InfectionsNCT04190316
Factors Influencing the Fecal Relative Abundance of ESBL-producing Enterobacteriaceae in Intensive Care (BLSE-REA).
A study testing Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU in people with ESBL-producing Enterobacteriaceae Infections, run by University Hospital, Angers.
Trial summary
Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) pose a major problem among antimicrobial resistance. The worldwide spread of theses bacteria may be responsible for 10 million death in 2050. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESBL-producing Enterobacteriaceae Infections
- What is being tested?
- Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jan 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Positive sample for ESBL-PE at admission of during ICU stay
- Patient's or relative's consent
Who cannot join
- Women pregnant, parturient or breast-feeding during the study period
- Patient deprived of liberty by judicial or administrative decision
- Patient undergoing psychiatric care under duress
- Patient subject to a legal protection measure
- Patient with no social security coverage
About this study
Official title: Study of the Fecal Relative Abundance (RA) of ESBL-producing Enterobacteriaceae (ESBL-PE) in Intensive Care (BLSE-REA) : What Are the Factors Influencing the Fecal RA of ESBL-PE in ICU ?
Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) pose a major problem among antimicrobial resistance. The worldwide spread of theses bacteria may be responsible for 10 million death in 2050. Infection with ESBL-PE are associated with a worse prognosis because of delay in the start of adequate antibiotic treatment, especially for severe infections. It has been proposed to identify colonized patients to predict the risk of infection and the risk of nosocomial cross transmission.
This qualitative approach has limit as only 5 to 20% of patients will develop an infection with ESBL-PE. The fecal relative abundance (RA) of ESBL-PE is a ratio of ESBL-PE among enterobacteriaceae that could identify high-risk patients of infection or cross transmission. ESBL-PE RA may be highly variable in patient with antibiotic exposure depending on the molecule received but dynamic data is missing.
The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
Read the detailed description
Antimicrobial resistance is rising since decades with a risk of million of death in the future. Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) have expanded exponentially since 15 years and represent with Carbapenemase-PE one of the major challenges in resistance control. The burden of ESBL-PE infections is major in intensive care units (ICU) because of the delay to identify an effective antibiotic treatment (highly associated with outcome) and because of a higher risk of nosocomial cross transmission.
Identification of digestive carrier of ESBL-PE is based on a qualitative result that categorize the patient as a carrier or as non-carrier. This result makes it impossible to individualize the measures to be taken for an ESBL-PE carrier.
Prevention of cross transmission has no formal guideline. Some practitioners in ICU have stopped to detect for ESBL-PE carriage (specially when prevalence is low) and other prefer to close the ward (specially during outbreak).
Empiric treatment of most infections in ESBL-PE carrier are based on last-resort antibiotic (i.e. carbapenem) until microbiological results of a clinical simple is available.
A quantitative approach based on fecal relative abundance (RA) of ESBL-PE (ratio between ESBL-PE and enterobacteriaceae) has been proposed to individualize the risk of urinary tract infection (UTI) for ambulatory patients. In this setting, a fecal carriage with a very low RA of ESBL-PE safely rule out a risk of infection with ESBL-PE and patients with a high RA had an increased risk of UTI infection with ESBL-PE. Large variations of RA ESBL-PE carriage was observed and prediction of the level of RA was not possible for a patient.
A high variation in fecal RA of ESBL-PE is probable in ICU because of a high proportion of antibiotic exposure. Using the RA in ICU for ESBL-PE carrier could make it possible to identify patients who need for carbapenem in their empiric treatment and those who need continuing contact precautions to prevent cross transmission.
The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
- Being tested
- Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU
- Keywords
- Extended-spectrum beta-lactamase, Carriage, Cross transmission, Intensive care unit, Fecal relative abundance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICUOther
ESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of patient and patient-care environment ESBL | Other | ESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU. Receives: Other: Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fecal ESBL-PE RA in the ICU
Factors associated with changes in the RA of ESBL-PE fecal carriage will be analyzed. RA is expressed by the ratio of ESBL-PE and total enterobacteriaceae.
Measured: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Secondary outcomes (6)
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE infection
Looking for a threshold of ESBL-PE RA in fecal sample and a high risk of ESBL-PE infection
Measured: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE cross-transmission
Is there an association between a high ESBL-PE RA in fecal samples and cross-transmission
Measured: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Association between changes in ESBL-PE RA in fecal samples and multiple-site colonization
Is there an association between a high ESBL-PE RA in fecal samples and multiple-site colonization
Measured: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Association between changes in ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE
Is there an association between a high ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE
Measured: Twice a week till day 30.
Comparison of changes in ESBL-PE RA between different bacteria species during ICU stay
Are there differences of RA between different species of ESBL-PE
Measured: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Incidence of high level of EBSL-PE RA in ICU fecal carriers
High level of RA is defined by a ratio of ESBL-PE on total enterobacteriaceae > 0.2
Measured: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESBL-producing Enterobacteriaceae InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190316
- Sponsor's protocol ID
- RCB 2019-A02861-56
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Fecal Relative Abundance (RA) of ESBL-producing Enterobacteriaceae (ESBL-PE) in Intensive Care (BLSE-REA) : What Are the Factors Influencing the Fecal RA of ESBL-PE in ICU ?
- ClinicalTrials.gov ID
- NCT04190316
- Acronym / sponsor ID
- RCB 2019-A02861-56
- Keywords
- Extended-spectrum beta-lactamase, Carriage, Cross transmission, Intensive care unit, Fecal relative abundance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 9 Dec 2019 (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.
Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) pose a major problem among antimicrobial resistance. The worldwide spread of theses bacteria may be responsible for 10 million death in 2050. Infection with ESBL-PE are associated with a worse prognosis because of delay in the start of adequate antibiotic treatment, especially for severe infections. It has been proposed to identify colonized patients to predict the risk of infection and the risk of nosocomial cross transmission.
This qualitative approach has limit as only 5 to 20% of patients will develop an infection with ESBL-PE. The fecal relative abundance (RA) of ESBL-PE is a ratio of ESBL-PE among enterobacteriaceae that could identify high-risk patients of infection or cross transmission. ESBL-PE RA may be highly variable in patient with antibiotic exposure depending on the molecule received but dynamic data is missing.
The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
Detailed description
Antimicrobial resistance is rising since decades with a risk of million of death in the future. Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) have expanded exponentially since 15 years and represent with Carbapenemase-PE one of the major challenges in resistance control. The burden of ESBL-PE infections is major in intensive care units (ICU) because of the delay to identify an effective antibiotic treatment (highly associated with outcome) and because of a higher risk of nosocomial cross transmission.
Identification of digestive carrier of ESBL-PE is based on a qualitative result that categorize the patient as a carrier or as non-carrier. This result makes it impossible to individualize the measures to be taken for an ESBL-PE carrier.
Prevention of cross transmission has no formal guideline. Some practitioners in ICU have stopped to detect for ESBL-PE carriage (specially when prevalence is low) and other prefer to close the ward (specially during outbreak).
Empiric treatment of most infections in ESBL-PE carrier are based on last-resort antibiotic (i.e. carbapenem) until microbiological results of a clinical simple is available.
A quantitative approach based on fecal relative abundance (RA) of ESBL-PE (ratio between ESBL-PE and enterobacteriaceae) has been proposed to individualize the risk of urinary tract infection (UTI) for ambulatory patients. In this setting, a fecal carriage with a very low RA of ESBL-PE safely rule out a risk of infection with ESBL-PE and patients with a high RA had an increased risk of UTI infection with ESBL-PE. Large variations of RA ESBL-PE carriage was observed and prediction of the level of RA was not possible for a patient.
A high variation in fecal RA of ESBL-PE is probable in ICU because of a high proportion of antibiotic exposure. Using the RA in ICU for ESBL-PE carrier could make it possible to identify patients who need for carbapenem in their empiric treatment and those who need continuing contact precautions to prevent cross transmission.
The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of patient and patient-care environment ESBL | Other | Other: Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICUESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Positive sample for ESBL-PE at admission of during ICU stay
- Patient's or relative's consent
Key exclusion criteria (5 listed)
- Women pregnant, parturient or breast-feeding during the study period
- Patient deprived of liberty by judicial or administrative decision
- Patient undergoing psychiatric care under duress
- Patient subject to a legal protection measure
- Patient with no social security coverage
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 |
|---|---|---|
| Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICUESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU. | Other | Evaluation of patient and patient-care environment ESBL |
Primary outcome
Changes in fecal ESBL-PE RA in the ICU
Time frame: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Factors associated with changes in the RA of ESBL-PE fecal carriage will be analyzed. RA is expressed by the ratio of ESBL-PE and total enterobacteriaceae.
6 secondary outcomes
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE infection
Time frame: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE cross-transmission
Time frame: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Association between changes in ESBL-PE RA in fecal samples and multiple-site colonization
Time frame: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Association between changes in ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE
Time frame: Twice a week till day 30.
Comparison of changes in ESBL-PE RA between different bacteria species during ICU stay
Time frame: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Incidence of high level of EBSL-PE RA in ICU fecal carriers
Time frame: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU in people with ESBL-producing Enterobacteriaceae Infections, run by University Hospital, Angers.
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 5 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 9 Dec 2019. 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?
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?
Changes in fecal ESBL-PE RA in the ICU (time frame: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.). 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 9 Dec 2019.