Gentamicin with a narrow-spectrum beta-lactam for early community-acquired sepsis
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
This trial tests whether giving gentamicin plus a narrow-spectrum beta-lactam to adults with suspected community-acquired sepsis is as safe as using a broad-spectrum beta-lactam alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Akershus Academic / other |
| Locations | 5 sites (Bergen, Bergen and 4 other locations) |
| Trial ID | NCT06712641 on ClinicalTrials.gov |
What this trial studies
Hospitalized adults with suspected community-acquired sepsis and a NEWS2 score ≥5 receive either empirical gentamicin combined with a narrow-spectrum beta-lactam or a broad-spectrum beta-lactam such as cefotaxime or piperacillin–tazobactam. The primary hypothesis is that the proportion of patients experiencing acute kidney injury or death will be similar between the two groups (non-inferiority). Investigators also expect the aminoglycoside-based regimen to reduce use of broad-spectrum agents and thereby lessen antibiotic pressure. Patients with severe chronic kidney disease, septic shock with multiorgan failure, or infections requiring specific antimicrobial therapy are excluded.
Who should consider this trial
Good fit: Adults (≥18) hospitalized with suspected community-acquired sepsis who have NEWS2 ≥5, can give informed consent, and do not meet exclusion criteria such as severe chronic kidney failure are eligible.
Not a fit: Patients with established severe renal impairment (eGFR <30 mL/min/1.73m2), those presenting in septic shock with multiorgan failure, or those with suspected drug-resistant or organism-specific infections (e.g., ESBL, MRSA, fungal) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could allow safer use of narrow-spectrum antibiotics, reduce unnecessary broad-spectrum therapy, and help curb antibiotic resistance.
How similar studies have performed: Guidelines and observational data support aminoglycoside combination therapy, but randomized evidence directly comparing this regimen to broad-spectrum beta-lactams is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bergen, Bergen and 4 other locations
- Haukeland University Hospital — Bergen, Bergen, Norway (Not_yet_recruiting)
- Lovisenberg Diakonal Hospital — Oslo, Oslo, Norway (Not_yet_recruiting)
- St. Olav's Hospital — Trondheim, Trondheim, Norway (Not_yet_recruiting)
- Akershus University Hospital — Lørenskog, Norway (Recruiting)
- Oslo University Hospital Ullevål — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Magnus N Lyngbakken, MD PhD
- Email: magnus.lyngbakken@medisin.uio.no
- Phone: +4793408837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.