AMIKACIN for Ventilator-associated tracheobronchitis|Ventilator-associated pneumonia

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- First episode of VAT during the ICU stay\n- Coverage by the French health insurance system (Social Security)\n- Written informed consent obtained from the patient, or, if the patient is not able to give written consent, from his or her legally designated representative (trusted person designated by the patient, or failing that a family member) and, failing that due to the urgency of the situation, inclusion will be performed by the investigator within the therapeutic window\n- For woman of childbearing potential: a negative pregnancy test result at the time of inclusion and contraception using an acceptable birth control method (CTFG recommendation)"}

Exclusion criteria

• {"criterion_text":"- Previous VAP due to the pathogens responsible for VAT during the same ICU stay\n- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship)\n- Moribund patient\n- End-of-life decision\n- Previous inclusion in the present study\n- On-going VAP (currently being treated)\n- VAT due to pathogens with intrinsic naturally amikacin resistance\n- On-going therapy with amikacin IV\n- AKI stage 2 or 3 of the KDIGO classification and/or advanced chronic kidney failure (glomerular filtration rate <30 mL/min), except in patients under renal replacement therapy (RRT)\n- Grade B or C cirrhosis (Child-Pugh classification)\n- Scheduled extubation within 24h\n- Known allergy to aminoglycosides\n- Myasthenia gravis"}

Primary endpoints

• {"endpoint_text":"- Incidence of transition from VAT to VAP at Day 28","definition_or_measurement_approach":"Measured as incidence of transition from ventilator-associated tracheobronchitis (VAT) to ventilator-associated pneumonia (VAP) by Day 28"}

Secondary endpoints

• {"endpoint_text":"- Incidence of transition from VAT to VAP at Day 7","definition_or_measurement_approach":"Measured as incidence of transition from VAT to VAP by Day 7"}
• {"endpoint_text":"- Overall incidence of a first VAP episode (all pathogens) at Day 28","definition_or_measurement_approach":"Measured as incidence of a first VAP episode (all pathogens) by Day 28"}
• {"endpoint_text":"- Overall incidence of a first VAP episode due to MDRB at Day 28","definition_or_measurement_approach":"Measured as incidence of a first VAP episode due to multidrug-resistant bacteria (MDRB) by Day 28"}
• {"endpoint_text":"- Time to resolution of clinical signs of VAT","definition_or_measurement_approach":"Measured as time (duration) until clinical signs of VAT resolve (time-to-event)"}
• {"endpoint_text":"- Persistence of the pathogens responsible for VAT on ETA at Day 7","definition_or_measurement_approach":"Measured as presence/persistence of VAT pathogens on endotracheal aspirate (ETA) at Day 7"}
• {"endpoint_text":"- Total duration of MV","definition_or_measurement_approach":"Measured as total duration of mechanical ventilation (MV)"}
• {"endpoint_text":"- Number of ventilator-free days at Day 28","definition_or_measurement_approach":"Measured as number of ventilator-free days up to Day 28"}
• {"endpoint_text":"- Number of defined daily doses of systemic antibiotics (i.e., intravenous and/or enteral administration) at Day 28","definition_or_measurement_approach":"Measured as defined daily doses of systemic antibiotics (IV and/or enteral) at Day 28"}
• {"endpoint_text":"- Incidence of ICU-acquired intestinal colonization with MDRB at Day 28","definition_or_measurement_approach":"Measured as incidence of ICU-acquired intestinal colonization with MDRB by Day 28"}
• {"endpoint_text":"- Overall incidence of ICU-acquired infection due to MDRB at Day 28","definition_or_measurement_approach":"Measured as incidence of ICU-acquired infection due to MDRB by Day 28"}
• {"endpoint_text":"- ICU and hospital LOS","definition_or_measurement_approach":"Measured as length of stay (LOS) in ICU and in hospital"}
• {"endpoint_text":"- All-cause Day-28 and Day-90 mortality rates","definition_or_measurement_approach":"Measured as all-cause mortality at Day 28 and at Day 90"}
• {"endpoint_text":"- HRQoL in survivors at Day 90","definition_or_measurement_approach":"Measured as health-related quality of life in survivors at Day 90 (assessed using the EQ-5D-5L questionnaire)"}
• {"endpoint_text":"- Occurrence of respiratory adverse events related to amikacin nebulization (safety analysis)","definition_or_measurement_approach":"Measured as incidence of respiratory adverse events potentially related to amikacin nebulization (safety analysis)"}
• {"endpoint_text":"- Incidence of AKI at Day 28 (safety analysis)","definition_or_measurement_approach":"Measured as incidence of acute kidney injury (AKI) at Day 28 using KDIGO/AKI criteria (safety analysis)"}
• {"endpoint_text":"- Pharmacokinetics of inhaled amikacin (pre-planned subsample).","definition_or_measurement_approach":"Measured as pharmacokinetic parameters of inhaled amikacin in a pre-planned subsample (serum concentrations at specified timepoints)"}

France

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

174

Number Of Sites

17

Number Of Participants

250

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France