Cefazolin versus flucloxacillin in bloodstream infections caused by methicillin-susceptible Staphylococcus aureus (MSSA): a quasi-randomized, prospective, observational study (CASABI)
- Conditions
- bloodstream infection due to Methicillin-susceptible Staphylococcus aureus (MSSA)A41.0Sepsis due to Staphylococcus aureus
- Registration Number
- DRKS00014583
- Lead Sponsor
- niklinik Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
1. patients (> 18 years) with their 1st episode of a monomicrobial bloodstream infection due to Methicillin-sensitive Staphylococcus aureus (MSSA), proven by = 1 positive blood culture sample
2. patients willing and able to give written informed consent to participate in the study
3. Cefazolin or Flucloxacillin as part of the antibiotic regimen or planned transition to an antibiotic regimen that includes Cefazolin or Flucloxacillin
Exclusion Criteria
1. patients with polymicrobial bloodstream infection
2. patients unable to give informed consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability and safety of Cefazolin versus Flucloxacillin summarized as weighted sums of all side effects during therapy (grade of side effects according to CTCAE). Also the rate of premature discontinuation of therapy due to side effects for both substances will be recorded. <br><br>
- Secondary Outcome Measures
Name Time Method - Evaluation of the clinical and microbiological efficacy of Cefazolin versus Flucloxacillin for the therapy of bloodstream infections due to MSSA (Methicillin-susceptible Staphylococcus aureus) by categorical judgement at the end of i.v.-therapy, latest after 90 days. <br>- Follow-up after 90 days to record MSSA-specific and overall mortality<br>- sample size calculation and demonstration of the feasibility of a multicentric, randomised-controlled non-inferiority study <br><br>