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CompletedNCT02860247MALDI-TRAcUpdated Jul 2, 2018

Rapid Detection of Bacterial Resistance by MALDI-TOF MS and Antibiotic Savings

An observational study in Sepsis With Escherichia Coli, sponsored by Centre Hospitalier Universitaire de Besancon. Completed. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
103
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sepsis With Escherichia Coli

Keywords

  • antibiotic
  • MALDI-TOF MS
  • susceptibility testing
03

In context

Escherichia coli Infections

96 studies on the registry are indexed under Escherichia coli Infections; 17 are open to participants now.

This study's enrollment of 103 is below the median of 200 across 35 observational studies indexed under Escherichia coli Infections.

Browse Escherichia coli Infections studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.

Inclusion criteria

  • All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.

Exclusion criteria

Exclusion Criteria:

  • Patients without sepsis with E. coli
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Comparison of antibiotic resistance

    assessed by MALDI-TOF MS with that of the reference method (E-test)

    Time frame: 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.

    Time frame: Immediate

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02860247
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Aug 9, 2016
Start date
May 2016
Primary completion
Nov 2017
Completion
Dec 2017
Last update
Jul 2, 2018

Study contacts

Marlène Sauget
principal investigator · CHU Besançon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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