Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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