Inhaled antibiotics aim to beat pneumonia in ECMO patients
NCT ID NCT06602557
First seen Jul 08, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This study investigates whether inhaling the antibiotic amikacin can better treat pneumonia caused by gram-negative bacteria in patients on veno-arterial ECMO (a heart-lung bypass machine). Standard antibiotics often fail in these patients, possibly because the bypass reduces blood flow to the lungs, limiting drug delivery. The trial compares inhaled amikacin plus standard care versus standard care alone, measuring bacterial clearance after five days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Amikacin (inhaled)
- What this could lead to
- If it works, this could offer a new way to treat pneumonia in critically ill patients on ECMO, potentially reducing treatment failure.
- What could go wrong
- This is a small early-phase trial, so results may not apply broadly. Inhaled antibiotics can cause airway irritation or bronchospasm, and the drug may not reach infected areas effectively.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient 18 years or older 2. Circulatory assistance by veno-arterial ECMO for at least 24 hours prior to documentation of pneumonia 3. Invasive mechanical ventilation 4. 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. 5. 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). 6. Probabilistic antibiotic therapy with piperacillin - tazobactam 7. 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. 8. Patient affiliated to social security (excluding AME) Exclusion Criteria: 1. Known allergy to amikacin or another aminoglycoside or to an auxiliary drug or to any of their excipients. 2. Contraindication to the administration of amikacin or its excipients listed in the summary of product characteristics. 3. Contraindication to the administration of an auxiliary drug or to one of its excipients listed in the summary of product characteristics. 4. Contraindications to nebulization 5. Intravenous antibiotic therapy started more than 72 hours before randomization 6. Probabilistic venous antibiotic therapy other than piperacillin - tazobactam 7. Administration of inhaled antibiotics within 7 days prior to inclusion 8. Positive pregnancy test for women of childbearing potential 9. Presence of HIV infection with CD4 count inferior to 200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema 10. Presence of renal insufficiency with creatinine clearance inferior to 15 ml/min, with the exception of patients receiving continuous renal purification or daily hemodialysis sessions as part of their intensive care unit management. 11. Patent moribund (SAPS II superior to 75) or high probability of death within 48 hours 12. Patient under legal protection (curatorship, guardianship or safeguard of justice) 13. Participating in another interventional clinical trial or within the exclusion period at the end of a previous study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Pitié-Salpêtrière
RECRUITINGParis, 75013, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which works better: one antibiotic or two for this superbug?
- Could a simple sedation plan transform recovery for ECMO patients?