About this trial
Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. However, fear of renal complications due to gentamicin and concern for lacking evidence for efficiency commonly leads to the use of broad spectrum betalactam therapy, a larger driver of antibiotic resistance.
In patients with suspected community acquired sepsis, the investigators hypothesize that empirical combination therapy with narrow spectrum betalactams and aminoglycosides is safe and non-inferior to empirical therapy with broad spectrum betalactams. More specifically, the investigators hypothesize that the proportion of patients with acute kidney injury or death will be similar between these two treatment groups. Furthermore, the investigators hypothesize that the aminoglycoside-based regimen has lesser impact on the gut microbiome. Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required but failed to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In this context, novel initiatives aiming at reducing use of antibiotics are direly needed.
Eligibility criteria
Qualifiers
Hospitalized
Adults 18 year or older
Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy
National Early Warning Score 2 (NEWS2) ≥ 5
Disqualifiers
Established chronic kidney failure (eGFR < 30 ml/min/1.73m2)
Presentation with septic shock with multiorgan failure
Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial infection)
Current or recent use of nephrotoxic drugs (e.g cisplatin within previous 2 months)
Trial design
Treatments tested in this trial
- Gentamicin + narrow spectrum betalactam
- Cefotaxime
- Piperacillin-tazobactam
Treatment groups
Sponsors and collaborators
University Hospital, Akershus
Lead sponsor
Ullevaal University Hospital
Collaborator