Sepsis With Escherichia ColiMALDI-TRAcNCT02860247
Rapid Detection of Bacterial Resistance by MALDI-TOF MS and Antibiotic Savings
An observational study of Sepsis With Escherichia Coli, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
This study aims at determining within a short time (<3h) the susceptibility to clinical isolates of E. coli to the major antibiotics directly from positive blood cultures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis With Escherichia Coli
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- 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: All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.
Who may be able to join
- All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.
Who cannot join
- Patients without sepsis with E. coli
About this study
This study aims at determining within a short time (<3h) the susceptibility to clinical isolates of E. coli to the major antibiotics directly from positive blood cultures.
Read the detailed description
The resistance to antibiotic is a concern for the great majority of pathogenic bacteria. The proportion of antibiotic-resistant bacteria is particularly high in hospital settings. The accumulation of resistance mechanisms can lead to multidrug resistance, therapeutic impasses and a subsequent higher mortality of infected patients. The use of antibiotics in humans and animals creates a selection pressure that favors the dissemination of antibiotic resistant strains. It's necessary to optimize antibiotic consumption to limit the spread of these bacteria. It requires both the fast bacterial identification and the fast determination of their resistance profile in order to use narrower-spectrum compounds.
Usually antibiotic susceptibility testing usually takes 18-24 hours. Mass Spectrometry type Matrix-Assisted Laser Desorption Ionization Time-Of-Flight (MALDI-TOF MS) has become a valuable tool in clinical laboratories for pathogen identification. Preliminary data showed that susceptible and resistant bacteria can be differentiated within 1 or 2 hours with a new technology called 'MS-ASTRA' based on a lower global peak intensity in the presence of the antibiotic of interest (at a concentration corresponding to the susceptibility breakpoint defined by the EUCAST) than in its absence. The objective of this study is to evaluate the performances of this new MALDI-TOF MS method on a panel of wild-type and resistant clinical isolates.
This study aims to determine the resistance of Escherichia coli isolates to cefotaxime, piperacillin-tazobactam, amoxicillin and to implement the method to positive blood cultures. Minimal Inhibitory Concentrations will be determined the standard agar dilution method.
Results and full analyze are deliverable within 2 years. The data obtained with the MS-ASTRA technique will be compared with the resistance status of the clinical isolates. The shortest incubation time (1 or 2 hours) that gives the more accurate result will be evaluate.The antibiotic savings that the implementation of this new method could have allowed will be evaluate.
- Conditions
- Sepsis With Escherichia Coli
- Keywords
- antibiotic, MALDI-TOF MS, susceptibility testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of antibiotic resistance
assessed by MALDI-TOF MS with that of the reference method (E-test)
Measured: Immediate
Secondary outcomes (1)
Antibiotic savings that could have occurred if the MALDI-TOF MS method was implemented
comparison between the antibiotherapy received by the infected patients (during the first 48 hours) and the adapted treatment which would have been set up from the premature detection of the resistance.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis With Escherichia ColiStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlène Sauget, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860247
- Sponsor's protocol ID
- P/2016/300
- Acronym
- MALDI-TRAc
- Status last verified
- Jun 2018
- First submitted
- 1 Aug 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Detection of Bacterial Resistance by MALDI-TOF MS and Antibiotic Savings
- ClinicalTrials.gov ID
- NCT02860247
- Acronym / sponsor ID
- MALDI-TRAc / P/2016/300
- Conditions
- Sepsis With Escherichia Coli
- Keywords
- antibiotic, MALDI-TOF MS, susceptibility testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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 aims at determining within a short time (<3h) the susceptibility to clinical isolates of E. coli to the major antibiotics directly from positive blood cultures.
Detailed description
The resistance to antibiotic is a concern for the great majority of pathogenic bacteria. The proportion of antibiotic-resistant bacteria is particularly high in hospital settings. The accumulation of resistance mechanisms can lead to multidrug resistance, therapeutic impasses and a subsequent higher mortality of infected patients. The use of antibiotics in humans and animals creates a selection pressure that favors the dissemination of antibiotic resistant strains. It's necessary to optimize antibiotic consumption to limit the spread of these bacteria. It requires both the fast bacterial identification and the fast determination of their resistance profile in order to use narrower-spectrum compounds.
Usually antibiotic susceptibility testing usually takes 18-24 hours. Mass Spectrometry type Matrix-Assisted Laser Desorption Ionization Time-Of-Flight (MALDI-TOF MS) has become a valuable tool in clinical laboratories for pathogen identification. Preliminary data showed that susceptible and resistant bacteria can be differentiated within 1 or 2 hours with a new technology called 'MS-ASTRA' based on a lower global peak intensity in the presence of the antibiotic of interest (at a concentration corresponding to the susceptibility breakpoint defined by the EUCAST) than in its absence. The objective of this study is to evaluate the performances of this new MALDI-TOF MS method on a panel of wild-type and resistant clinical isolates.
This study aims to determine the resistance of Escherichia coli isolates to cefotaxime, piperacillin-tazobactam, amoxicillin and to implement the method to positive blood cultures. Minimal Inhibitory Concentrations will be determined the standard agar dilution method.
Results and full analyze are deliverable within 2 years. The data obtained with the MS-ASTRA technique will be compared with the resistance status of the clinical isolates. The shortest incubation time (1 or 2 hours) that gives the more accurate result will be evaluate.The antibiotic savings that the implementation of this new method could have allowed will be evaluate.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.
Key inclusion criteria (1 listed)
- All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.
Key exclusion criteria (1 listed)
- Patients without sepsis with E. coli
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of antibiotic resistance
Time frame: Immediate
assessed by MALDI-TOF MS with that of the reference method (E-test)
1 secondary outcome
Antibiotic savings that could have occurred if the MALDI-TOF MS method was implemented
Time frame: Immediate
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 2 Jul 2018.
- Individual participant dataSharing planned: No
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.
Marlène Sauget principal investigator
CHU Besançon
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis With Escherichia Coli, 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 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 2 Jul 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?
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?
Comparison of antibiotic resistance (time frame: Immediate). 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 2 Jul 2018.