Aminoglycosides in Early Sepsis

Sponsor
University Hospital, Akershus
Study ID
NCT06712641
Phase
PHASE4
Status
Recruiting
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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gentamicin + narrow spectrum betalactam — DRUG
    Empirical therapy for suspected community-acquired sepsis with gentamicin + narrow spectrum betalactam (either one of penicillin, ampicillin, or cloxacillin)
  • Cefotaxime — DRUG
    Empirical therapy for suspected community-acquired sepsis with cefotaxime
  • Piperacillin-tazobactam — DRUG
    Empirical therapy for suspected community-acquired sepsis with piperacillin-tazobactam

Study Details

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.

Key Dates

First listed
Dec 2, 2024
Start date
Apr 23, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
May 31, 2033

Study Design

Enrollment
1,900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Gentamicin + narrow spectrum betalactam
    Empirical therapy for suspected community-acquired sepsis with gentamicin + narrow spectrum betalactam (either one of penicillin, ampicillin, or cloxacillin)
  • Active Comparator: Cefotaxime or piperacillin-tazobactam
    Empirical therapy for suspected community-acquired sepsis with broad spectrum betalactam (either one of cefotaxime or piperacillin-tazobactam)

Primary Outcome Measure

30-day mortality [ Time Frame: Up to 30 days after randomization ]

Central Contacts

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