Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425367
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Impact of Performing a Rapid Antibiotic Susceptibility Test MHR-SIR on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia Controlled Randomized Cluster and Cross-over Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
MHR-Blood
Brief Summary:
Bacteremia is defined as the presence of bacteria in the blood They can potentially lead to life-threatening septic shock
Effective probabilistic antibiotic therapy must therefore be initiated immediately after blood cultures have been taken
To diagnose bacteremia blood culture bottles must first be incubated which allows bacterial growth and early detection Then as soon as the sample is positive an antibiogram of the incriminated bacterium is carried out by inoculation on MH Mueller Hinton medium This diffusion antibiogram is the reference method and is obtained 24 hours after the vial is positive ie around 48 hours after blood cultures are taken
American recommendations agree that it is crucial to use rapid diagnostic tests to obtain the antibiogram Antibiotic susceptibility test data can be used to broaden the spectrum of antibiotics in the event of ineffective therapy They can also be used to reduce the spectrum of broad-spectrum antibiotics This is part of the proper use of antibiotics and the reduction of multi-resistant bacteria MRB or highly resistant bacteria HRB Finally it is also possible to carry out an early oral relay thus avoiding intravenous infusions and their complications and potentially reducing hospitalization times
The investigators have evaluated a rapid antibiogram by diffusion on MHR-SIR Mueller-Hinton Rapid-SIR medium from the blood culture bottle The investigators were able to obtain antibiogram results 7 hours after blood culture positivity with excellent correlation compared with the standard method after 24 hours incubation on MH Mueller-Hinton The antibiotics tested were the same as with the standard method
Secondly The investigators were able to evaluate prospectively the impact of diffusion antibiotic susceptibility testing on MHR-SIR medium on early modification of antibiotic therapy in bacteremia on 167 patients Antibiotic susceptibility test data on MHR-SIR enabled us to adapt antibiotic therapy 8 hours after blood culture positivity for 74 patients 44 Antibiotic therapy was ineffective for 30 patients 18 and was therefore extended It also enabled us to reduce the spectrum of antibiotic therapy in particular through early oral relay for 44 patients 26
The aim of this multicenter trial is to validate on a large scale this strategy for obtaining rapid antibiotic susceptibility test results with significant consequences in terms of optimizing antibiotic therapy
Effective probabilistic antibiotic therapy must therefore be initiated immediately after blood cultures have been taken
To diagnose bacteremia blood culture bottles must first be incubated which allows bacterial growth and early detection Then as soon as the sample is positive an antibiogram of the incriminated bacterium is carried out by inoculation on MH Mueller Hinton medium This diffusion antibiogram is the reference method and is obtained 24 hours after the vial is positive ie around 48 hours after blood cultures are taken
American recommendations agree that it is crucial to use rapid diagnostic tests to obtain the antibiogram Antibiotic susceptibility test data can be used to broaden the spectrum of antibiotics in the event of ineffective therapy They can also be used to reduce the spectrum of broad-spectrum antibiotics This is part of the proper use of antibiotics and the reduction of multi-resistant bacteria MRB or highly resistant bacteria HRB Finally it is also possible to carry out an early oral relay thus avoiding intravenous infusions and their complications and potentially reducing hospitalization times
The investigators have evaluated a rapid antibiogram by diffusion on MHR-SIR Mueller-Hinton Rapid-SIR medium from the blood culture bottle The investigators were able to obtain antibiogram results 7 hours after blood culture positivity with excellent correlation compared with the standard method after 24 hours incubation on MH Mueller-Hinton The antibiotics tested were the same as with the standard method
Secondly The investigators were able to evaluate prospectively the impact of diffusion antibiotic susceptibility testing on MHR-SIR medium on early modification of antibiotic therapy in bacteremia on 167 patients Antibiotic susceptibility test data on MHR-SIR enabled us to adapt antibiotic therapy 8 hours after blood culture positivity for 74 patients 44 Antibiotic therapy was ineffective for 30 patients 18 and was therefore extended It also enabled us to reduce the spectrum of antibiotic therapy in particular through early oral relay for 44 patients 26
The aim of this multicenter trial is to validate on a large scale this strategy for obtaining rapid antibiotic susceptibility test results with significant consequences in terms of optimizing antibiotic therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None