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Completed

NCT Number: NCT02860247

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients without sepsis with E. coli

Treatment and study plan

Primary outcomes

  1. Comparison of antibiotic resistance

    Time frame: Immediate

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

Secondary outcomes

  1. Antibiotic savings that could have occurred if the MALDI-TOF MS method was implemented

    Time frame: Immediate

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: MALDI-TRAc

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.