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Aminoglycosides in Early Sepsis

Study acronym: AGES
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Apr 2026 to Apr 23, 2026 · Site details revised at 5 of 5 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2026 to Apr 23, 2026
    • Site details revised at 5 of 5 sites
  2. Start date: Oct 2025 to Apr 2026 Study sites: 2 to 5 · Secondary endpoints: 9 to 8v4 Show 2 more changesShow less
    • Study sites: 2 to 5
    • Secondary endpoints: 9 to 8

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jun 2025 to Oct 2025 Enrollment target: 1940 to 1900 · Eligibility criteria expanded, about 7 wordsv3 Show 2 more changesShow less
    • Enrollment target: 1940 to 1900
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  4. Interventions: Cefotaxime or piperacillin-tazobactam (Drug), Gentamicin + narrow spectrum betalactam (Drug) to Cefotaxime (Drug), Gentamicin + narrow spectrum betalactam (Drug), Piperacillin-tazobactam (Drug) Site contacts updated at 2 of 2 sitesv2 Show 1 more changeShow less
    • Site contacts updated at 2 of 2 sites
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06712641
Lead Sponsor University Hospital, Akershus
Collaborators: Ullevaal University Hospital
Conditions Sepsis
Enrollment 1,900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov