Bacterial ResistanceAB-RUNNCT03226314
Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae in Reunion Island
An observational study of Bacterial Resistance, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
In its report dated april 2014, World Health Organization confirms antibiotic resistance dissemination in all parts of the world, in hospitals and in community and worries about a possible comeback to a pre-antibiotic era during the 21st century. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Resistance
- What is being tested?
- stool sample
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteReunion
- Study dates
- 21 Nov 2017to 30 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: community patients admitted in emergency ward or in intensive care unit for any condition.
Who may be able to join
- Patients:
- aged over 18 years old
- admitted in emergency ward or intensive care of the university hospital of Reunion Island
- who received the patient information notice and who gave their consent
- who have a stool sample performed in the 48 hours following admission
- who understand and can read French
Who cannot join
- Patients:
- transferred from a short-term, middle-term or long-term stay health facility
- who have a stool sample performed more than 48 hours following admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae (Prevalence, Resistance Mechanisms and Risk Factors) in Reunion Island
In its report dated april 2014, World Health Organization confirms antibiotic resistance dissemination in all parts of the world, in hospitals and in community and worries about a possible comeback to a pre-antibiotic era during the 21st century. For the last 15 years, third-generation cephalosporins resistant enterobacteriaceae (3GCREB) prevalence is continuously increasing. Community 3GCREB prevalence has not been studied whereas several observations made in Reunion Island hospital suggest a diffusion in community. In this situation of world-wide and regional extension of bacterial resistance, the investigator offers to study bacterial resistance to antibiotic in Reunion Island community.
Read the detailed description
The investigator is focused on E. coli species exhibiting BLSE or metallo-betalactamases production that could be encountered du to the increasing level of migratory flow in Reunion Island.
Fecal sample collection will be used for further investigations on bacterial typology.
- Conditions
- Bacterial Resistance
- Being tested
- stool sample
- Keywords
- bacterial multi-resitance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool sampleProcedure or surgery
study will be proposed to all patients entering emergency ward or intensive care unit in Reunion Island university hospital. Upon consent, a stool sample will be taken (either directly on emitted stools or by rectal sampling) and analysed for enterobacteriaceae.
| Study group | Role | What they receive |
|---|---|---|
| stool sampled community patients | community patients entering emergency ward or intensive care unit in Reunion Island university hospital and having the stools sampled for bacterial analysis. Receives: Procedure: stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digestive prevalence rate of 3GCREB
estimate of digestive prevalence rate of 3GCREB in participating patients and extrapolation to Reunion Island community population.
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start21 Nov 2017
- Primary completion1 Dec 2018
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien JAUBERT, MD, Principal investigator, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226314
- Sponsor's protocol ID
- 2015/CHU/14
- Acronym
- AB-RUN
- Status last verified
- Mar 2019
- First submitted
- 3 Mar 2017
- Last updated
- 7 Mar 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 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae (Prevalence, Resistance Mechanisms and Risk Factors) in Reunion Island
- ClinicalTrials.gov ID
- NCT03226314
- Acronym / sponsor ID
- AB-RUN / 2015/CHU/14
- Conditions
- Bacterial Resistance
- Keywords
- bacterial multi-resitance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 21 Jul 2017 (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.
In its report dated april 2014, World Health Organization confirms antibiotic resistance dissemination in all parts of the world, in hospitals and in community and worries about a possible comeback to a pre-antibiotic era during the 21st century. For the last 15 years, third-generation cephalosporins resistant enterobacteriaceae (3GCREB) prevalence is continuously increasing. Community 3GCREB prevalence has not been studied whereas several observations made in Reunion Island hospital suggest a diffusion in community. In this situation of world-wide and regional extension of bacterial resistance, the investigator offers to study bacterial resistance to antibiotic in Reunion Island community.
Detailed description
The investigator is focused on E. coli species exhibiting BLSE or metallo-betalactamases production that could be encountered du to the increasing level of migratory flow in Reunion Island.
Fecal sample collection will be used for further investigations on bacterial typology.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stool sampled community patients | – | Procedure: stool samplecommunity patients entering emergency ward or intensive care unit in Reunion Island university hospital and having the stools sampled for bacterial analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community patients admitted in emergency ward or in intensive care unit for any condition.
Key inclusion criteria (6 listed)
- aged over 18 years old
- admitted in emergency ward or intensive care of the university hospital of Reunion Island
- who received the patient information notice and who gave their consent
- who have a stool sample performed in the 48 hours following admission
- who understand and can read French
Key exclusion criteria (3 listed)
- transferred from a short-term, middle-term or long-term stay health facility
- who have a stool sample performed more than 48 hours following admission.
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 |
|---|---|---|
| stool samplestudy will be proposed to all patients entering emergency ward or intensive care unit in Reunion Island university hospital. Upon consent, a stool sample will be taken (either directly on emitted stools or by rectal sampling) and analysed for enterobacteriaceae. | Procedure or surgery | stool sampled community patients |
Primary outcome
Digestive prevalence rate of 3GCREB
Time frame: through study completion, an average of 1 day
estimate of digestive prevalence rate of 3GCREB in participating patients and extrapolation to Reunion Island community population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
Julien JAUBERT, MD principal investigator
CHU La Réunion
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 Bacterial Resistance, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 6 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: status not confirmed, as of the sponsor's last update on 7 Mar 2019. 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 Reunion. 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?
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?
Digestive prevalence rate of 3GCREB (time frame: through study completion, an average of 1 day). 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 7 Mar 2019.