Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02860247
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2016-08-01
Brief Title:
Rapid Detection of Bacterial Resistance by MALDI-TOF MS and Antibiotic Savings
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Rapid Detection of Bacterial Resistance by MALDI-TOF MS and Antibiotic Savings
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MALDI-TRAc
Brief 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
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 Its 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 evaluateThe antibiotic savings that the implementation of this new method could have allowed will be evaluate
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 evaluateThe antibiotic savings that the implementation of this new method could have allowed will be evaluate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None