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Nebulized Amikacine for Ventilator associated gram negative Pneumonia in ECMO veno-arterial patients: A randomized Pilot Study (NAVAP-ECMO)
EU CTIS ID: 2023-509722-22-00
What this study is testing
To show that the administration of inhaled amikacin for 5 days in addition to the usual antibiotic therapy in adult patients with documented Gram-negative Bacillus-positive pulmonary arterial disease undergoing VA-ECMO improves the bacterial eradication rate at D5 compared with the usual antibiotic therapy alone.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years old
- Circulatory assistance by ECMO veno-arterial for at least 24 hours prior to documentation of pneumonia
- Invasive mechanical ventilation
- Diagnostic suspicion of pneumonia based on suggestive criteria (presence of at least 2 of the following criteria): fever >38. 5°C, hyperleukocytosis >11 × 109 l-1 or leukopenia <4 × 109 l-1, purulent tracheobronchial secretions, altered oxygenation with the need to increase FiO2 on the ECMO or ventilator for the same SaO2 or PaO2 target, new or persistent pulmonary infiltrate(s) on chest X-ray in bed, or an image suggestive of pneumonia on a chest CT scan, or consolidation of an appearance suggestive of an infectious origin on lung ultrasound
- Microbiological confirmation of gram-negative ventilator-associated pneumonia by quantitative culture on bronchoalveolar lavage (BAL, significance threshold > 104 CFU/ml) or protected distal sampling (PDP, significance threshold > 103 CFU/ml)
- Probabilistic antibiotic therapy with piperacillin - tazobactam
You likely can't join if
- Known allergy to amikacin or another aminoglycoside
- Patient moribund or with a high probability of death within 48 hours
- Patient under legal protection (curatorship, guardianship or safeguard of justice)
- Participating in another interventional clinical trial or within the exclusion period at the end of a previous study
- Contraindications to the administration of amikacin
- Contraindications to nebulisation
See the full eligibility criteria
- Age ≥ 18 years old
- Circulatory assistance by ECMO veno-arterial for at least 24 hours prior to documentation of pneumonia
- Invasive mechanical ventilation
- Diagnostic suspicion of pneumonia based on suggestive criteria (presence of at least 2 of the following criteria): fever >38. 5°C, hyperleukocytosis >11 × 109 l-1 or leukopenia <4 × 109 l-1, purulent tracheobronchial secretions, altered oxygenation with the need to increase FiO2 on the ECMO or ventilator for the same SaO2 or PaO2 target, new or persistent pulmonary infiltrate(s) on chest X-ray in bed, or an image suggestive of pneumonia on a chest CT scan, or consolidation of an appearance suggestive of an infectious origin on lung ultrasound
- Microbiological confirmation of gram-negative ventilator-associated pneumonia by quantitative culture on bronchoalveolar lavage (BAL, significance threshold > 104 CFU/ml) or protected distal sampling (PDP, significance threshold > 103 CFU/ml)
- Probabilistic antibiotic therapy with piperacillin - tazobactam
- Informed consent obtained from the patient or his/her trusted support person if unable to consent at the time of inclusion, or inclusion procedure in an emergency situation
- Patient affiliated to a social security scheme (excluding AME)
- Known allergy to amikacin or another aminoglycoside
- Patient moribund or with a high probability of death within 48 hours
- Patient under legal protection (curatorship, guardianship or safeguard of justice)
- Participating in another interventional clinical trial or within the exclusion period at the end of a previous study
- Contraindications to the administration of amikacin
- Contraindications to nebulisation
- Intravenous antibiotic therapy started more than 72 hours before administration of the first dose of study treatment
- Probabilistic venous antibiotic therapy other than piperacillin-tazobactam
- Administration of inhaled antibiotics in the 7 days prior to inclusion
- Positive pregnancy test for women of childbearing potential
- Presence of HIV infection with CD4 count <200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema
- Presence of renal insufficiency with creatinine clearance < 15 ml/min, with the exception of patients receiving continuous renal purification or daily haemodialysis sessions as part of their intensive care treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.