2024-514042-36-00招募中3 期
Combination lock01 - Impact of aminoglycosides-based antibiotics combination and protective isolation on outcomes in critically-ill neutropenic patients with sepsis:A randomized 2 by 2 factorial design randomized pragmatic trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 7
- 主要终点
- Day-90 mortality
研究概览
简要总结
To evaluate the impact on day-90 mortality of two strategies, separately, using a 2x2 factorial design RCT: • Intervention 1 - routine association of aminoglycoside to initial antibiotic therapy when compared to standard of care • Intervention 2 - lack of routine use of protective isolation when compared to standard of care
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Admitted in one of the participating ICU
- •Sepsis or septic shock as defined by SEPSIS3 definition
- •Underlying tumor, allogeneic stem cell transplantation or hematological malignancy
- •Neutropenia (defined by either absolute neutrophil count <500/mm3 or leucocytes <1000/mm3) related to an underlying malignancy or its treatment
- •Informed or deferred consent
排除标准
- •Pregnancy and breastfeeding
- •Myasthenia gravis
- •Concomitant administration of intravenous Polymyxin - Delay between onset of sepsis and inclusion>24 hours
- •Moribund patients (death expected within 48 hours by attending physician)
- •Previous participation to this study
- •No affiliation to social security
- •Patients under legal protection according to French Law
- •Patient having received more than 1 injection of aminoglycosides in the 3 days preceding ICU admission
- •Contraindication to aminoglycosides as mentioned in SpC section 4.3
- •Hypersensitivity to amikacin, to other antibiotics from the aminoglycoside family, or to any excipient from the amikacin used
- •Patients with documented allergy to aminoglycosides
结局指标
主要结局
Day-90 mortality
Day-90 mortality
次要结局
- Day-28 and hospital mortality
- Incidence and severity of AKI according to KDIGO definition
- Major Adverse Kidney Events at day-28 and day 90 (composite of death, new renal replacement therapy, or persistent renal dysfunction)
- Incidence of clinically apparent loss of hearing at end of ICU stay and day 90
- Rate of adherence to adequate hand hygiene as assessed by external observer
- Incidence density of selected serious adverse events including unexpected cardiac arrest
- Incidence density of new bacterial, viral or fungal episode
- Number of days free from organ support therapy (mechanical ventilation, vasopressors or RRT) at day 28
- Rate of clinical cure
- Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation.
- Number of day free of antibiotic therapy at day-28
- Duration of aminoglycoside therapy, rate of aminoglycoside overdosage according to residual concentration and overuse when compared to experts recommendations
研究者
Investigateur Coordonnateur
Scientific
Assistance Publique Hopitaux De Paris
研究点 (7)
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