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 - APHP180690

Assistance Publique Hopitaux De Paris0 个研究点目标入组 340 人开始时间: 2024年6月11日最近更新: 2024年8月21日

适应症

试验速览

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•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

•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

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