Short-course aminoglycosides as adjunctive treatment in adults with sepsis
- Conditions
- Sepsis
- Registration Number
- NL-OMON29602
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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) or Modified Early Warning Score (MEWS) = 5.
5) Requiring intravenous antibiotic treatment and hospitalization.
1) Working diagnosis at the ER of pneumonia.
2) Chemotherapy induced neutropenia as this is considered a separate entity in the guidelines.
3) 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 treatment.
5) Indication for empirical coverage of ESBL-producing gram-negative bacteria according to the Dutch sepsis guidelines, i.e. known colonization or infection with ESBL-producing gram-negative bacteria in the prior year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 30-day all-cause mortality
- Secondary Outcome Measures
Name Time Method Secondary outcomes include duration of IC and hospital admission, quality of life, nephrotoxicity, ototoxicity and costs. In a cost-effectiveness analysis we will determine the costs per quality-adjusted life year gained.