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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 28, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT06712641). This is a study registration, not published results. Lead sponsor: University Hospital, Akershus. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 1900 participants (ESTIMATED). Conditions: Sepsis. Interventions: DRUG: Gentamicin + narrow spectrum betalactam; DRUG: Cefotaxime; DRUG: Piperacillin-tazobactam. Primary outcome measures: 30-day mortality , Up to 30 days after randomization; 30-day acute kidney injury , Up to 30 days after randomization. Brief summary: 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.