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NCT Number: NCT06712641

Aminoglycosides in Early Sepsis

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. 30-day mortality

    Time frame: Up to 30 days after randomization

    All-cause mortality up to 30 days after randomization

  2. 30-day acute kidney injury

    Time frame: Up to 30 days after randomization

    Any acute kidney injury up to 30 days after randomization

Secondary outcomes

  1. In-hospital mortality

    Time frame: During index hospitalization (commonly up to 30 days)

    All-cause mortality during index hospitalization

  2. Duration of hospital stay

    Time frame: During index hospitalization (commonly up to 30 days)

    Duration of index hospitalization (days)

  3. Duration of intensive care stay

    Time frame: During index hospitalization (commonly up to 30 days)

    Duration of stay in intensive care unit (days)

  4. Duration of ventilator therapy

    Time frame: During index hospitalization (commonly up to 30 days)

    Duration of therapy with invasive mechanical ventilation (days)

  5. Duration of vasopressor therapy

    Time frame: During index hospitalization (commonly up to 30 days)

    Duration of therapy with vasoactive (vasopressor) (days)

  6. Hospital readmissions

    Time frame: Up to 30 days after discharge from index hospitalization

    Readmission after discharge from index hospitalization

  7. Post-discharge mortality

    Time frame: Up to 30 days after discharge from index hospitalization

    All-cause mortality after discharge from index hospitalization

  8. Duration of antibiotic treatment

    Time frame: During index hospitalization (commonly up to 30 days)

    Duration of antibiotic therapy during index hospitalization (days of therapy, DOT)

Study contacts

Contact information is provided by the study sponsor or research team.

Kristian Tonby, MD PhD

CONTACT

[email protected]

+4741550565

Magnus N Lyngbakken, MD PhD

CONTACT

[email protected]

+4793408837

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Ullevaal University Hospital

Registry information

Official study title

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

Acronym: AGES

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Dec 2, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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