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" 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)." | Clinical Trials | Clareo Health

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" 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)."

NCT06602557•Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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 therapy is tailored to the germs identified. One hypothesis to explain this particularly high failure rate is the reduced pulmonary blood flow associated with ECMO offloading of the heart. Although there are no data to date on the pulmonary penetration of antibiotics in patients undergoing VA-ECMO, this phenomenon of pulmonary hypoperfusion could contribute to altering the alveolocapillary diffusion of antibiotics, thereby reducing their concentration in the pulmonary parenchyma. Our hypothesis is that amikacin nebulization could increase bacterial clearance and, ultimately, limit treatment failure or recurrence of gram-negative bacilli (GNB) pneumonia in patients undergoing VA-ECMO.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Key Dates

Start Date

November 15, 2024

Primary Completion Date

May 15, 2025

Completion Date

May 15, 2026

Last Updated

September 19, 2024

Enrollment

ESTIMATED participants

Conditions

Pneumonia, BacterialExtracorporeal Membrane Oxygenation

Interventions

Amikacin

DRUG

Standard of care

DRUG

Contacts

Pauline DUREAU, MD, PhD

CONTACT

01 84 82 76 89 pauline.dureau@aphp.fr

Alexis CALOC, Clinical project manager

CONTACT

01 42 16 24 37 alexis.caloc@aphp.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

" 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)."

Inclusion Criteria

Exclusion Criteria

Platform of Randomized Adaptive Clinical Trials in Critical Illness

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients

"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"

Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation

Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure