Gentamicin with a narrow-spectrum beta-lactam for early community-acquired sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Haukeland University Hospital
  Bergen, Bergen, Norway Recruiting
• Lovisenberg Diakonal Hospital
  Oslo, Oslo, Norway Recruiting
• Akershus University Hospital
  Lørenskog, Norway Recruiting
• Oslo University Hospital Ullevål
  Oslo, Norway Recruiting
• St. Olav's Hospital
  Trondheim, Trondheim, Norway Not yet recruiting
• Ålesund Hospital, Helse Møre og Romsdal HF
  Ålesund, Norway Not yet recruiting

Study contacts

• Study coordinator: Magnus N Lyngbakken, MD PhD
• Email: magnus.lyngbakken@medisin.uio.no
• Phone: +4793408837

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care

  This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07922213

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

• Neutrophil EMR3 as a biomarker for sepsis in ICU patients

  Researchers will test whether measuring EMR3 on neutrophils helps diagnose sepsis, monitor progression, and predict outcomes in adults in Chinese ICUs.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang · NCT07896018

• Thymalfasin added to standard care for adults with sepsis and immune dysfunction

  This study tests whether thymosin alpha-1 helps restore immune function in adults with sepsis who have weakened immunity.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07866118

• Multicenter group study of sepsis and ARDS in China

  This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.

  Recruiting at 24 sites Shanghai Zhongshan Hospital · Xiamen, Fujian and 23 other locations · NCT07863908

• Non-invasive hemodynamic guidance for sepsis care on medical wards

  This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.

  Recruiting at 2 sites Regione del Veneto - AULSS n. 7 Pedemontana · Pisa, Pisa and 1 other locations · NCT07863323

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.