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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis With Escherichia Coli

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 Type: Observational
• Enrollment (Actual): 103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients without sepsis with E. coli

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of antibiotic resistance	assessed by MALDI-TOF MS with that of the reference method (E-test)	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediate

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Marlène Sauget, CHU Besançon

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: antibiotic; susceptibility testing; MALDI-TOF MS
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Escherichia coli Infections
• Other Study ID Numbers: P/2016/300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO