Actively Recruiting
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
Led by Fondation Hôpital Saint-Joseph · Updated on 2024-09-27
960
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on adult patients with bacteremia caused by Enterobacterales bacteria. Bacteremia means bacteria are present in the blood and can lead to serious complications like septic shock. The study aims to evaluate a rapid antibiotic susceptibility test called MHR-SIR that produces results 7 hours after blood culture positivity, compared to the standard test that takes 24 hours. This rapid test may help doctors adjust antibiotic therapy sooner to improve treatment. Participants are randomly assigned to one of two groups: one group receives the rapid antibiotic susceptibility testing on MHR-SIR medium, and the other group receives the standard testing on Mueller-Hinton (MH) medium. Both tests are done from blood culture bottles, but the rapid test results are available much faster. This design allows researchers to compare how quickly and effectively antibiotic treatments can be modified based on test results. During the study, patients' antibiotic therapies are monitored to see if adjustments are made within 12 hours after the test results. Researchers will track the time to change antibiotic spectrum, the use of oral antibiotics versus intravenous therapy, and length of hospital stay. The study includes hospitalized adults with confirmed Enterobacterales bacteremia and involves follow-up assessments up to one month. The goal is to validate this rapid testing method to optimize antibiotic use and potentially reduce complications from broad-spectrum antibiotics.
CONDITIONS
Brief Title
Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hospitalized in a clinical department at a participating center
- Diagnosed with bacteremia confirmed by positive blood culture
- Positive blood culture specifically for Enterobacterales bacteria
- Affiliated with a health insurance scheme
- Provided free, informed, and express oral consent by patient or relative
You will not qualify if you...
- Bacteremia caused by non-enterobacterial bacteria
- Under legal guardianship
- Deprived of liberty
- Under court protection
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day after blood culture positivity
Participants undergo antibiotic susceptibility testing using either rapid MHR-SIR or standard MH medium to determine the best antibiotic therapy.
1 visit (in-person)
Duration - Up to 1 month
Participants are monitored for antibiotic therapy adaptation, time to modify antibiotic spectrum, and length of hospital stay.
Follow-up visits as part of routine hospital care
Trial Site Locations
Total: 1 location
1
Hôpital Paris Saint Joseph
Paris, France
Actively Recruiting
Research Team
H
Helene BEAUSSIER
J
Juliette COURTIADE MAHLER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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