" a Randomized Pilot Study of the Benefit of Nebulized Amikacin in the Treatment of Gram-negative Bacillus Pneumonia Acquired During Mechanical Ventilation in Patients Receiving Extracorporeal Membrane Veno-arterial Oxygenation (ECMO-VA)."

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the potential benefits of using a medication called nebulized amikacin to treat pneumonia caused by certain bacteria in patients who are on a life-support system known as veno-arterial ECMO. Pneumonia is a common and serious complication for these patients, and current treatments often don’t work well. The researchers believe that nebulizing amikacin, which means delivering the medication directly into the lungs as a mist, may help clear the infection better and reduce the chances of treatment failing.

To be eligible for the study, participants need to be at least 18 years old and have been receiving ECMO support for at least 24 hours before pneumonia is suspected. They also need to be on a ventilator and have specific signs of pneumonia, confirmed by tests. Participants will be closely monitored throughout the trial, and informed consent will be required to ensure they understand the study and agree to participate. It’s important to note that certain conditions, like allergies to the medication or other serious health issues, may prevent someone from joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient 18 years or older
• • 2. Circulatory assistance by veno-arterial ECMO for at least 24 hours prior to documentation of pneumonia
• • 3. Invasive mechanical ventilation
• • 4. Diagnostic suspicion of pneumonia based on evocative criteria (presence of at least 2 of the following criteria): fever (superior to 38. 5°C), hypothermia (inferior to 36.0°C), hyperleukocytosis (superior to 11 × 10\^9 l-1) or leukopenia (inferior to 4 × 10\^9 l-1), purulent tracheobronchial secretions, altered oxygenation with need to increase FiO2 on ECMO or ventilator for the same SaO2 or PaO2 target, new or persistent pulmonary infiltrate(s) on chest x-ray in bed, or image suggestive of pneumonia on chest CT, or consolidation of appearance suggestive of an infectious origin on pulmonary ultrasound.
• • 5. And microbiological confirmation of Gram-negative ventilator-associated pneumonia by quantitative culture on bronchoalveolar lavage (BAL, significance threshold superior to 10\^4 CFU/ml) or protected distal sampling (PDP, significance threshold superior to 10\^3 CFU/ml).
• • 6. Probabilistic antibiotic therapy with piperacillin - tazobactam
• • 7. Informed consent obtained from the patient or trusted support person if unable to consent at the time of inclusion, or inclusion procedure in emergency situations.
• • 8. Patient affiliated to social security (excluding AME)
• Exclusion Criteria:
• • 1. Known allergy to amikacin or another aminoglycoside or to an auxiliary drug or to any of their excipients.
• • 2. Contraindication to the administration of amikacin or its excipients listed in the summary of product characteristics.
• • 3. Contraindication to the administration of an auxiliary drug or to one of its excipients listed in the summary of product characteristics.
• • 4. Contraindications to nebulization
• • 5. Intravenous antibiotic therapy started more than 72 hours before randomization
• • 6. Probabilistic venous antibiotic therapy other than piperacillin - tazobactam
• • 7. Administration of inhaled antibiotics within 7 days prior to inclusion
• • 8. Positive pregnancy test for women of childbearing potential
• • 9. Presence of HIV infection with CD4 count inferior to 200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema
• • 10. Presence of renal insufficiency with creatinine clearance inferior to 15 ml/min, with the exception of patients receiving continuous renal purification or daily hemodialysis sessions as part of their intensive care unit management.
• • 11. Patent moribund (SAPS II superior to 75) or high probability of death within 48 hours
• • 12. Patient under legal protection (curatorship, guardianship or safeguard of justice)
• • 13. Participating in another interventional clinical trial or within the exclusion period at the end of a previous study.