Clinical Trial

" 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 "

Study acronym: NAVAP-ECMO
Recruiting Phase 2
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-08-14
notable Primary completion pushed: 2028-05-20 -> 2028-08-10 2026-08-14
minor Completion pushed: 2028-05-20 -> 2029-02-10 2026-08-14
Trial Details
NCT Number NCT06602557
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Pneumonia, Bacterial, Extracorporeal Membrane Oxygenation
Enrollment 26 participants
Start Date 2026-08-10
Primary Completion 2028-08-10 (estimated)
Study Completion 2029-02-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-13