Resistant InfectionINOR BlactNCT03752476
Impact of Number of Rank of B-lactam Antibiotics on Emergence on Multidrug Resistant Bacteria
An observational study of Resistant Infection and Antibiotic Resistant Infection, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
This study evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug resistant bacteria colonization in intensive care It's retrospective case controle study. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistant Infection, Antibiotic Resistant Infection, Beta Lactam Resistant Bacterial Infection
- What is being tested?
- number of Beta lactam class prescription for the same infection
- Type of treatment
- Surgery or procedure
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 May 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017
Who may be able to join
- all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017
Who cannot join
- patient under guardianship
- patient allergic to Beta lactam
- colonization with mutidrug resistant the first week of hospitalization in intensive care unit
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug resistant bacteria colonization in intensive care
It's retrospective case controle study. Cases are colonized patient by multidrug resistant bacteria hospitalized in intensive care during the fist hospitalization in intensive care. Temoin are patients with the same characteristics than case but no colonized by multidrug resistant bacteria.
Read the detailed description
The emergence of multidrug resistant is a wordwide problem. B lactam resistant increase. The antibiotic prescription impact this problem.
B lactam antibiotic is prescribed everyday in intensive care unit. The switch of antibiotic is common. Antibiotic classes inclue a lot of rank with different spectum that impact the occurrence of resistant.
- Conditions
- Resistant Infection, Antibiotic Resistant Infection, Beta Lactam Resistant Bacterial Infection, Bacterial Resistance
- Being tested
- number of Beta lactam class prescription for the same infection
- Keywords
- antibiotic resistant, multidrug resistant, Beta lactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
number of Beta lactam class prescription for the same infectionProcedure or surgery
Each number of Beta lactam prescription without interruption are compared
| Study group | Role | What they receive |
|---|---|---|
| case | Patients are colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017. Receives: Procedure: number of Beta lactam class prescription for the same infection | |
| control | Patients aren't colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017. Receives: Procedure: number of Beta lactam class prescription for the same infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Beta lactam class prescription
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant InfectionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estelle Dossot, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752476
- Sponsor's protocol ID
- Dossot
- Acronym
- INOR Blact
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 26 Nov 2018
- 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 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Number of Rank of B-lactam Antibiotics on Emergence on Multidrug Resistant Bacteria
- ClinicalTrials.gov ID
- NCT03752476
- Acronym / sponsor ID
- INOR Blact / Dossot
- Conditions
- Resistant Infection, Antibiotic Resistant Infection, Beta Lactam Resistant Bacterial Infection, Bacterial Resistance
- Keywords
- antibiotic resistant, multidrug resistant, Beta lactam
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 26 Nov 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.
This study evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug resistant bacteria colonization in intensive care
It's retrospective case controle study. Cases are colonized patient by multidrug resistant bacteria hospitalized in intensive care during the fist hospitalization in intensive care. Temoin are patients with the same characteristics than case but no colonized by multidrug resistant bacteria.
Detailed description
The emergence of multidrug resistant is a wordwide problem. B lactam resistant increase. The antibiotic prescription impact this problem.
B lactam antibiotic is prescribed everyday in intensive care unit. The switch of antibiotic is common. Antibiotic classes inclue a lot of rank with different spectum that impact the occurrence of resistant.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Procedure: number of Beta lactam class prescription for the same infectionPatients are colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017. |
| control | – | Procedure: number of Beta lactam class prescription for the same infectionPatients aren't colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017
Key inclusion criteria (1 listed)
- all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017
Key exclusion criteria (3 listed)
- patient under guardianship
- patient allergic to Beta lactam
- colonization with mutidrug resistant the first week of hospitalization in intensive care unit
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 |
|---|---|---|
| number of Beta lactam class prescription for the same infectionEach number of Beta lactam prescription without interruption are compared | Procedure or surgery | case, control |
Primary outcome
number of Beta lactam class prescription
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistant Infection and Antibiotic Resistant Infection, run by Centre Hospitalier Universitaire de Besancon.
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 1 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 26 Nov 2018. 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 ESTELLE DOSSOT (+33645578372, estelle.dossot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of Beta lactam class prescription (time frame: 3 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 26 Nov 2018.