Hôpital Pitié-Salpêtrière
Paris, 75013, France
Location status: Recruiting
NCT Number: NCT06602557
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Paris, 75013, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients included in the inhaled amikacin group will receive inhaled antibiotic therapy by nebulization of amikacin at a dose of 25 mg/kg in 1 daily dose (+/- 3 hours apart), within 6 hours of randomization and for a total duration of 5 days.
Patients included in the standard of care group will not receive any nebulization. They will receive Standard care alone.
Time frame: Day 5
Bacterial eradication rate, defined as absence of germs on direct examination and negative culture of a tracheal aspirate taken on day 5 (D5) after randomization and at least 12 hours after the last administration of inhaled amikacin.
Time frame: Day 5
Clinical cure rate, defined as disappearance of clinical signs suggestive of pneumonia, biological inflammatory syndrome and correction of haematosis disorders, at D5.
Time frame: Day 5
Pneumonia persistence rate defined as the presence of the pathogen identified at a significant level on culture of tracheal aspirate at D5.
Time frame: Day 0 to Day 5
Difference between CPIS score at D5 and CPIS score at randomization.
Time frame: Day 0 to Day 5
Difference between ultrasound pulmonary aeration score at D5 and pulmonary aeration score at randomization.
Time frame: Day 0 to Day 5
Quantifying and analysing adverse events and serious adverse events
Time frame: Day 1
Pharmacokinetic analysis of plasma concentrations of the piperacillin - tazobactam combination
Time frame: Day 1
Measurement of the alveolar fluid penetration ratio (AUC* alveolar fluid / AUC plasma) of piperacillin-tazobactam in patients on ECMO-VA after 2 days of intravenous antibiotic administration.
*Area Under the Curve
Time frame: Day 1 to Day 5
Measurement of the plasma concentration of Amikacin in patients on ECMO-VA in the treatment group between D1 and D5.
Time frame: Day 1
Measurement of the alveolar fluid concentration of Amikacin in patients on ECMO-VA after one nebulization in the treatment group (after 24 hours of treatment)
Contact information is provided by the study sponsor or research team.
Alexis PEREZ CALOC, Clinical project manager
CONTACT
Pauline DUREAU, MD, PhD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: NAVAP-ECMO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03711331
Bacterial Infections, Bacterial Infections and Mycoses
Lille, France
View Trial DetailsNCT02689531
Bacterial Infections, Bacterial Infections and Mycoses
Birmingham, Alabama, United States
View Trial DetailsNCT07406334
Bacterial Infections, Bacterial Infections and Mycoses
Soweto, Johannesburg, Gauteng, South Africa
View Trial DetailsNCT06238297
Bacterial Infections, Bacterial Infections and Mycoses
Bari, Italy
View Trial Details