Actively Recruiting
Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection
Led by University Hospital, Basel, Switzerland · Updated on 2024-12-16
36
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all".
CONDITIONS
Official Title
Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent or confirmation of patient rights by an independent physician if the patient cannot sign
- Age 18 years or older
- Complicated Staphylococcus aureus infection defined as bloodstream infection or deep-seated infection without bloodstream infection
- Intended or active treatment with flucloxacillin or cefazolin started less than 24 hours ago
You will not qualify if you...
- Patients receiving hemodialysis or with estimated glomerular filtration rate (eGFR) less than 10 ml/min
- Patients undergoing Cytosorb therapy
- Patients with liver cirrhosis classified as Child B or Child C
- Patients likely to stop flucloxacillin or cefazolin treatment within 48 hours due to treatment failure, switch to oral medication, palliative care, allergy, or expected discharge or transfer within 48 hours
- Patients with polymicrobial infection except likely contaminants such as Staphylococcus epidermidis or Cutibacterium acnes
- Patients with methicillin-resistant Staphylococcus aureus (MRSA) infection
- Participation in another investigational drug study within 30 days before or during this study
- Previous participation in this study
- Any uncontrolled or significant concurrent illness that increases risk or limits study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Basel, Division of Internal Medicine
Basel, Switzerland, 4031
Actively Recruiting
Research Team
M
Michael Osthoff, PD Dr. med.
CONTACT
S
Sarah Dräger, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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