Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602557
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAVAP-ECMO
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None