Pneumonia Clinical Trials

Find Pneumonia Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Hôpital Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Pauline DUREAU, MD, PhD
pauline.dureau@aphp.fr
01 84 82 76 89
Backup
Alexis PEREZ CALOC, Clinical project manager
alexis.caloc@aphp.fr
01 42 16 24 37
Time Frame
Start Date: 2026-08-10
Estimated Completion Date: 2029-02-10
Participants
Target number of participants: 26
Treatments
Experimental: Amikacine nebulization associated with Standard of care
Active_comparator: Standard of care
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov