Short-course aminoglycosides as adjunctive treatment in adults with sepsis - SAGA

niversity Medical Center Utrecht0 个研究点目标入组 3,140 人开始时间: 2021年7月7日最近更新: 2022年5月2日

研究概览

暂无简介。

•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.
•a. The working diagnosis set by the ER physician must state one of these three origin or ‘sepsis’ without mentioning a suspected focus
•b. If there is no working diagnosis noted, the differential diagnosis should be assessed. If the differential diagnosis consist of urinary or abdominal infections only, a patient can participated in the study.
•c. If the differential diagnosis is unclear, very wide (for example: Infection dd urinary tract infection dd pneumonia dd erysipelas dd abdominal focus) or clear, but mentions other origins besides urinary or abdominal, the local PI must be consulted (preferably within 3 days after admission). The PI determines whether patient should be included, depending on how likely a specific differential diagnosis is. If unclear, or very likely urological or abdominal, the patient can be included.
•4) National Early Warning Score (NEWS) or Modified Early Warning Score (MEWS) = 5.
•5) Requiring intravenous antibiotic treatment and hospitalization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3140

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•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.

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