Resistance BacterialMODERNNCT03477084
Understanding and Modeling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities
An observational study of Resistance Bacterial and Enterobacteriaceae Infections, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The continuing spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) is among the most important problems in antimicrobial resistance. It is also a good model to investigate the epidemiological complexity of resistance in Enterobacteriaceae. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resistance Bacterial, Enterobacteriaceae Infections
- What is being tested?
- ESBL-producing enterobacteriaceae carriage
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 29 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Residents of the Bellevaux LTCF (Besançon - France) * Patients discharged from the University Hospital of Besançon and carrying ESBL-E. coli or K. pneumoniae and their household members
Who may be able to join
- Residents of the Bellevaux LTCF (Besançon - France)
- Patients discharged from the University Hospital of Besançon and carrying ESBL-E. coli or K. pneumoniae and their household members
Who cannot join
- Participation rejection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding and Modelling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities
The continuing spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) is among the most important problems in antimicrobial resistance. It is also a good model to investigate the epidemiological complexity of resistance in Enterobacteriaceae. Available data on the transmission determinants of ESBL-PE in community settings are scarce, methodologically limited and mostly based on single centre studies. A comprehensive investigation using present typing and modelling techniques is warranted to develop a sound quantitative understanding of the interactions involved. A consortium of investigators with diverse expertise from countries with high and low endemicity of ESBL-EP has been created. Transmission and persistence of ESBL-PE within households and long-term care facilities will be studied. Individual and group-level determinants for transmission and persistence will be quantified, together with other ecological variables including environmental, food and wastewater contamination. Advanced molecular typing techniques and state of the art analytical methods will be used. Data generated in this project will directly inform a suite of mathematical models which, in addition to encapsulating current understanding of the processes, will be used to explore the potential effectiveness of different interventions to control ESBL-PE spread. The expected outputs are a comprehensive characterisation of ESBL-PE transmission considering bacterial clones and mobile genetic elements, as well as individual and ecologic-level factors in different settings, to inform public health authorities about interventions that should be prioritised to control transmission of these organisms.
- Being tested
- ESBL-producing enterobacteriaceae carriage
- Medical subject headings
- Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESBL-producing enterobacteriaceae carriageBiological
Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae
| Study group | Role | What they receive |
|---|---|---|
| Long Term Care Facilities | Spread of ESBL-producing E. coli and K. pneumoniae among the residents of Long Term Care Facilities. Receives: Biological: ESBL-producing enterobacteriaceae carriage | |
| Households | Household transmission of ESBL-producing bacteria after hospital discharge of a patient carrying ESBL-producing E. coli or K. pneumoniae. Receives: Biological: ESBL-producing enterobacteriaceae carriage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transmission of ESBL-producing E. coli and K. pneumoniae (ESBL-E) in the community (LTCF residents and in households)
We will assess
- For the cohort 'LTCF': the number of LTCF residents contaminated with an ESBL-E from other residents or from the environment within 35 weeks.
- For the cohort 'Household': the number of people (sharing household with a ESBL-E carrying patient which has been discharged from the hospital) contaminated with ESBL-E within 4 months.
These two measurements will be aggregated to arrive at one reported value : the number of secondary cases from one index case (ratio).
Measured: For the cohort 'LTCF': 35 weeks ; For the cohort 'Household': 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Mar 2017
- Primary completion1 Jul 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance BacterialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, University Hospital Tuebingen, University Hospital, Geneva, UMC Utrecht, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Elise Robert, Study director, University Hospital of Besançon - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477084
- Sponsor's protocol ID
- MODERN
- Acronym
- MODERN
- Status last verified
- Jan 2020
- First submitted
- 12 Mar 2018
- Last updated
- 10 Mar 2022
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Modelling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities
- ClinicalTrials.gov ID
- NCT03477084
- Acronym / sponsor ID
- MODERN / MODERN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, University Hospital Tuebingen, University Hospital, Geneva, UMC Utrecht, University of Oxford
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 26 Mar 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 continuing spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) is among the most important problems in antimicrobial resistance. It is also a good model to investigate the epidemiological complexity of resistance in Enterobacteriaceae. Available data on the transmission determinants of ESBL-PE in community settings are scarce, methodologically limited and mostly based on single centre studies. A comprehensive investigation using present typing and modelling techniques is warranted to develop a sound quantitative understanding of the interactions involved. A consortium of investigators with diverse expertise from countries with high and low endemicity of ESBL-EP has been created. Transmission and persistence of ESBL-PE within households and long-term care facilities will be studied. Individual and group-level determinants for transmission and persistence will be quantified, together with other ecological variables including environmental, food and wastewater contamination. Advanced molecular typing techniques and state of the art analytical methods will be used. Data generated in this project will directly inform a suite of mathematical models which, in addition to encapsulating current understanding of the processes, will be used to explore the potential effectiveness of different interventions to control ESBL-PE spread. The expected outputs are a comprehensive characterisation of ESBL-PE transmission considering bacterial clones and mobile genetic elements, as well as individual and ecologic-level factors in different settings, to inform public health authorities about interventions that should be prioritised to control transmission of these organisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Term Care Facilities | – | Biological: ESBL-producing enterobacteriaceae carriageSpread of ESBL-producing E. coli and K. pneumoniae among the residents of Long Term Care Facilities. |
| Households | – | Biological: ESBL-producing enterobacteriaceae carriageHousehold transmission of ESBL-producing bacteria after hospital discharge of a patient carrying ESBL-producing E. coli or K. pneumoniae. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Residents of the Bellevaux LTCF (Besançon - France) * Patients discharged from the University Hospital of Besançon and carrying ESBL-E. coli or K. pneumoniae and their household members
Key inclusion criteria (2 listed)
- Residents of the Bellevaux LTCF (Besançon - France)
- Patients discharged from the University Hospital of Besançon and carrying ESBL-E. coli or K. pneumoniae and their household members
Key exclusion criteria (1 listed)
- Participation rejection
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 |
|---|---|---|
| ESBL-producing enterobacteriaceae carriageCarriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae | Biological | Households, Long Term Care Facilities |
Primary outcome
Transmission of ESBL-producing E. coli and K. pneumoniae (ESBL-E) in the community (LTCF residents and in households)
Time frame: For the cohort 'LTCF': 35 weeks ; For the cohort 'Household': 4 months
We will assess * For the cohort 'LTCF': the number of LTCF residents contaminated with an ESBL-E from other residents or from the environment within 35 weeks. * For the cohort 'Household': the number of people (sharing household with a ESBL-E carrying patient which has been discharged from the hospital) contaminated with ESBL-E within 4 months. These two measurements will be aggregated to arrive at one reported value : the number of secondary cases from one index case (ratio).
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 10 Mar 2022.
- 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.
Elise Robert study director
University Hospital of Besançon - France
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 Resistance Bacterial and Enterobacteriaceae Infections, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 2 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 10 Mar 2022. 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 France. 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?
Transmission of ESBL-producing E. coli and K. pneumoniae (ESBL-E) in the community (LTCF residents and in households) (time frame: For the cohort 'LTCF': 35 weeks ; For the cohort 'Household': 4 months). 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 10 Mar 2022.