Short-course aminoglycosides as adjunctive treatment in adults with sepsis
- Conditions
- infectionsepsis10004018
- Registration Number
- NL-OMON53650
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3140
1) Age >= 18 years
2) Presenting to the ER
3) Suspicion of bacterial infection of unknown origin, primary suspected
urinary origin or primary suspected abdominal origin.
4) National Early Warning Score (NEWS) >= 5.
5) Requiring intravenous antibiotic treatment and hospitalization.
1) Working diagnosis at the ED of pneumonia (even if other foci are mentioned
in the differential diagnosis).
2) Chemotherapy induced neutropenia as this is considered a separate entity in
the guidelines.
3) History of renal transplantation or pre-existing renal failure defined as a
GFR < 30, due to a relative contra-indication for aminoglycosides.
4) Allergy for cephalosporins or aminoglycosides, known prior to the start of
antibiotic treatment.
5) Pre-existing hearing impairment known at the moment of presentation in the
ER.
6) History of heart-, lung or liver transplantation.
7) Known myasthenia or botulism.
8) A patient who has had an indwelling catheter for a prolonged period or was
catheterized intermittently, because of the recommended empirical treatment
including an aminoglycoside according to the SWAB guidelines.
9) Use of the medication cyclosporine, cisplatin, neuromuscular acting muscle
relaxants, oral neomycin and oral paromomycin due to relative contra-indication
for aminoglycosides.
10) Known colonization with a 3rd generation cephalosporin resistant bacterium
including Pseudomonas, relevant in the context of the infection the patient is
admitted with.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>30-day all-cause mortality</p><br>
- Secondary Outcome Measures
Name Time Method