AMIKACIN SULFATE for Sepsis | Neutropenia

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Admitted in one of the participating ICU"}
• {"criterion_text":"- Sepsis or septic shock as defined by SEPSIS3 definition"}
• {"criterion_text":"- Underlying tumor, allogeneic stem cell transplantation or hematological malignancy"}
• {"criterion_text":"- Neutropenia (defined by either absolute neutrophil count <500/mm3 or leucocytes <1000/mm3) related to an underlying malignancy or its treatment"}
• {"criterion_text":"- Informed or deferred consent"}

Exclusion criteria

• {"criterion_text":"- Pregnancy and breastfeeding"}
• {"criterion_text":"- Myasthenia gravis"}
• {"criterion_text":"- Concomitant administration of intravenous Polymyxin - Delay between onset of sepsis and inclusion>24 hours"}
• {"criterion_text":"- Moribund patients (death expected within 48 hours by attending physician)"}
• {"criterion_text":"- Previous participation to this study"}
• {"criterion_text":"- No affiliation to social security"}
• {"criterion_text":"- Patients under legal protection according to French Law"}
• {"criterion_text":"- Patient having received more than 1 injection of aminoglycosides in the 3 days preceding ICU admission"}
• {"criterion_text":"- Contraindication to aminoglycosides as mentioned in SpC section 4.3"}
• {"criterion_text":"- Hypersensitivity to amikacin, to other antibiotics from the aminoglycoside family, or to any excipient from the amikacin used"}
• {"criterion_text":"- Patients with documented allergy to aminoglycosides"}

Primary endpoints

• {"endpoint_text":"- Day-90 mortality","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Day-28 and hospital mortality","definition_or_measurement_approach":"Mortality at day 28 and in-hospital"}
• {"endpoint_text":"- Incidence and severity of AKI according to KDIGO definition","definition_or_measurement_approach":"Assessed according to KDIGO definition"}
• {"endpoint_text":"- Major Adverse Kidney Events at day-28 and day 90 (composite of death, new renal replacement therapy, or persistent renal dysfunction)","definition_or_measurement_approach":"Composite endpoint: death, new renal replacement therapy, or persistent renal dysfunction assessed at day 28 and day 90"}
• {"endpoint_text":"- Incidence of clinically apparent loss of hearing at end of ICU stay and day 90","definition_or_measurement_approach":"Clinically apparent hearing loss assessed at ICU discharge and day 90"}
• {"endpoint_text":"- Rate of adherence to adequate hand hygiene as assessed by external observer","definition_or_measurement_approach":"Assessed by external observer measuring adherence to hand hygiene criteria"}
• {"endpoint_text":"- Incidence density of selected serious adverse events including unexpected cardiac arrest","definition_or_measurement_approach":"Incidence density of selected serious adverse events, including unexpected cardiac arrest"}
• {"endpoint_text":"- Incidence density of new bacterial, viral or fungal episode","definition_or_measurement_approach":"Incidence density of new infectious episodes (bacterial, viral, fungal)"}
• {"endpoint_text":"- Number of days free from organ support therapy (mechanical ventilation, vasopressors or RRT) at day 28","definition_or_measurement_approach":"Number of days alive and free from organ support (mechanical ventilation, vasopressors, RRT) up to day 28"}
• {"endpoint_text":"- Rate of clinical cure","definition_or_measurement_approach":"Rate of clinical cure of the infection motivating admission"}
• {"endpoint_text":"- Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation.","definition_or_measurement_approach":"Frequency of initial antibiotic therapy judged inadequate relative to microbiological documentation"}
• {"endpoint_text":"- Number of day free of antibiotic therapy at day-28","definition_or_measurement_approach":"Number of days alive and free of antibiotic therapy up to day 28"}
• {"endpoint_text":"- Duration of aminoglycoside therapy, rate of aminoglycoside overdosage according to residual concentration and overuse when compared to experts recommendations","definition_or_measurement_approach":"Duration of aminoglycoside therapy; overdosage defined by residual concentration; overuse compared to expert recommendations"}

France

Earliest CTIS Part Ii Submission Date

29-05-2024

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

680

Number Of Sites

10

Number Of Participants

340

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France