Aminoglycosides in Early Sepsis

Launched by UNIVERSITY HOSPITAL, AKERSHUS · Nov 27, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Aminoglycosides in Early Sepsis," is studying how effective and safe a specific combination of antibiotics is for patients suspected of having sepsis, a serious condition caused by infection. The researchers want to see if using a combination of narrow-spectrum antibiotics (which target specific bacteria) and aminoglycosides (like gentamicin) is as safe as using broader-spectrum antibiotics (which cover a wider range of bacteria). They believe that if this combination is safe, it could help reduce the use of broad-spectrum antibiotics, which can contribute to antibiotic resistance, a growing health concern.

To participate in this trial, individuals need to be hospitalized adults aged 18 or older who show signs of community-acquired sepsis and require antibiotics. They should have a specific score indicating the severity of their condition. However, people with certain health issues, such as chronic kidney problems or specific infections, will not be eligible. Participants will receive one of the antibiotic treatments being studied and will be monitored for any side effects, such as kidney injury or death, as well as changes to their gut bacteria. This trial is important because it aims to find a safer treatment approach that could benefit many patients while also tackling the issue of antibiotic resistance.

Gender

ALL

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