ebulized Amikacine for Ventilator associated gram negative Pneumonia in ECMO veno-arterial patients: A randomized Pilot Study (NAVAP-ECMO)

Phase 1

Conditions: gram-negative bacillus pneumonia acquired during mechanical ventilation in patients receiving Extracorporeal Membrane veno-arterial oxygenation
MedDRA version: 20.1Level: LLTClassification code: 10035701Term: Pneumonia gram-negative bacterial NOS Class: 10021881
MedDRA version: 20.0Level: SOCClassification code: 10021881Term: Infections and infestations Class: 1
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: CTIS2023-509722-22-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

Inclusion Criteria

Age = 18 years old, Circulatory assistance by ECMO veno-arterial for at least 24 hours prior to documentation of pneumonia, Invasive mechanical ventilation, Diagnostic suspicion of pneumonia based on suggestive criteria (presence of at least 2 of the following criteria): fever >38. 5°C, hyperleukocytosis >11 × 109 l-1 or leukopenia <4 × 109 l-1, purulent tracheobronchial secretions, altered oxygenation with the need to increase FiO2 on the ECMO or ventilator for the same SaO2 or PaO2 target, new or persistent pulmonary infiltrate(s) on chest X-ray in bed, or an image suggestive of pneumonia on a chest CT scan, or consolidation of an appearance suggestive of an infectious origin on lung ultrasound, Microbiological confirmation of gram-negative ventilator-associated pneumonia by quantitative culture on bronchoalveolar lavage (BAL, significance threshold > 104 CFU/ml) or protected distal sampling (PDP, significance threshold > 103 CFU/ml), Probabilistic antibiotic therapy with piperacillin - tazobactam, Informed consent obtained from the patient or his/her trusted support person if unable to consent at the time of inclusion, or inclusion procedure in an emergency situation, Patient affiliated to a social security scheme (excluding AME)

Exclusion Criteria

Known allergy to amikacin or another aminoglycoside, Patient moribund or with a high probability of death within 48 hours, Patient under legal protection (curatorship, guardianship or safeguard of justice), Participating in another interventional clinical trial or within the exclusion period at the end of a previous study, Contraindications to the administration of amikacin, Contraindications to nebulisation, Intravenous antibiotic therapy started more than 72 hours before administration of the first dose of study treatment, Probabilistic venous antibiotic therapy other than piperacillin-tazobactam, Administration of inhaled antibiotics in the 7 days prior to inclusion, Positive pregnancy test for women of childbearing potential, Presence of HIV infection with CD4 count <200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema, Presence of renal insufficiency with creatinine clearance < 15 ml/min, with the exception of patients receiving continuous renal purification or daily haemodialysis sessions as part of their intensive care treatment