NCT06712641 Aminoglycosides in Early Sepsis
| NCT ID | NCT06712641 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Akershus |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,900 participants in total. It began in 2026-04-23 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06712641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712641 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06712641 currently recruiting?
Yes, NCT06712641 is actively recruiting participants. Contact the research team at magnus.lyngbakken@medisin.uio.no for enrollment information.
Where is the NCT06712641 trial being conducted?
This trial is being conducted at Bergen, Norway, Oslo, Norway, Trondheim, Norway, Ålesund, Norway and 11 additional locations.
Who is sponsoring the NCT06712641 clinical trial?
NCT06712641 is sponsored by University Hospital, Akershus. The trial plans to enroll 1,900 participants.