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

Phase 1

Conditions: Adult patients admitted to intensive care
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2024-514042-36-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

Inclusion Criteria

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

Exclusion Criteria

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