Aminoglycosides in Early Sepsis
Recruiting
Phase 4
Interventional Study
Sepsis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,900 (estimated)
- Sponsor
- University Hospital, Akershus · Other
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About This Trial
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 th…
Trial Locations
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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/l…
Contacts