RecruitingPhase 4NCT06712641

Aminoglycosides in Early Sepsis

Aminoglycosides in Early Sepsis (AGES): A Randomized Pragmatic Clinical Trial Comparing Gentamicin and Narrow Spectrum Betalactams to Broad Spectrum Betalactams as Empirical Treatment in Patients With Suspected Sepsis


Sponsor

University Hospital, Akershus

Enrollment

1,900 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cefotaxime, a drug called Gentamicin + narrow spectrum betalactam, and others for people with sepsis. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGentamicin + narrow spectrum betalactam

Empirical therapy for suspected community-acquired sepsis with gentamicin + narrow spectrum betalactam (either one of penicillin, ampicillin, or cloxacillin)

DRUGCefotaxime

Empirical therapy for suspected community-acquired sepsis with cefotaxime

DRUGPiperacillin-tazobactam

Empirical therapy for suspected community-acquired sepsis with piperacillin-tazobactam


Locations(5)

Haukeland University Hospital

Bergen, Bergen, Norway

Lovisenberg Diakonal Hospital

Oslo, Oslo, Norway

St. Olav's Hospital

Trondheim, Trondheim, Norway

Akershus University Hospital

Lørenskog, Norway

Oslo University Hospital Ullevål

Oslo, Norway

View Full Details on ClinicalTrials.gov

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NCT06712641


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