Status:
NOT_YET_RECRUITING
" 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)."
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pneumonia, Bacterial
Extracorporeal Membrane Oxygenation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Pneumonia are the most frequent infectious complication in patients on Extracorporeal Membrane Oxygenation Veno-arterial (ECMO-VA), with a treatment failure rate of around 40%, even though antibiotic ...
Eligibility Criteria
Inclusion
- Patient 18 years or older
- Circulatory assistance by veno-arterial ECMO for at least 24 hours prior to documentation of pneumonia
- Invasive mechanical ventilation
- 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.
- 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).
- Probabilistic antibiotic therapy with piperacillin - tazobactam
- 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.
- Patient affiliated to social security (excluding AME)
Exclusion
- Known allergy to amikacin or another aminoglycoside or to an auxiliary drug or to any of their excipients.
- Contraindication to the administration of amikacin or its excipients listed in the summary of product characteristics.
- Contraindication to the administration of an auxiliary drug or to one of its excipients listed in the summary of product characteristics.
- Contraindications to nebulization
- Intravenous antibiotic therapy started more than 72 hours before randomization
- Probabilistic venous antibiotic therapy other than piperacillin - tazobactam
- Administration of inhaled antibiotics within 7 days prior to inclusion
- Positive pregnancy test for women of childbearing potential
- Presence of HIV infection with CD4 count inferior to 200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema
- 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.
- Patent moribund (SAPS II superior to 75) or 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.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06602557
Start Date
November 15 2024
End Date
May 15 2026
Last Update
September 19 2024
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