Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06712641

Aminoglycosides in Early Sepsis

Led by University Hospital, Akershus · Updated on 2026-04-24

1900

Participants Needed

5

Research Sites

366 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Akershus

Lead Sponsor

U

Ullevaal University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Aminoglycosides in Early Sepsis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations
Not Eligible

You will not qualify if you...

  • 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)
  • Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria, methicillin-resistant Staphylococcus aureus (MRSA), or other drug-resistant microbes necessitating specific antimicrobial therapy
  • Multiple myeloma
  • Renal transplantation
  • Renal replacement therapy
  • Myasthenia gravis
  • Known hypersensitivity to any of the study drugs
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Haukeland University Hospital

Bergen, Bergen, Norway

Not Yet Recruiting

2

Lovisenberg Diakonal Hospital

Oslo, Oslo, Norway

Not Yet Recruiting

3

St. Olav's Hospital

Trondheim, Trondheim, Norway

Not Yet Recruiting

4

Akershus University Hospital

Lørenskog, Norway, 1478

Actively Recruiting

5

Oslo University Hospital Ullevål

Oslo, Norway, 0450

Actively Recruiting

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Research Team

M

Magnus N Lyngbakken, MD PhD

CONTACT

K

Kristian Tonby, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Aminoglycosides in Early Sepsis | DecenTrialz