bloodstream infection due to Methicillin-susceptible Staphylococcus aureus (MSSA) A41.0
Conditions
Interventions
Group 1: All Patients with MSSA (Methicillin-susceptible Staphylococcus aureus) bloodstream infection who give informed consent to participate in the study and who receive either flucloxacillin or cef
Sponsors
Uniklinik Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: 1. patients with polymicrobial bloodstream infection 2. patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. - Follow-up after 90 days to record MSSA-specific and overall mortality - sample size calculation and demonstration of the feasibility of a multicentric, randomised-controlled non-inferiority study | — |
Countries
Germany
Contacts
Public ContactMarianne Breuninger
Uniklinik Köln, Klinik I für Innere Medizin, Klinische Infektiologie
Outcome results
None listed