Pneumonia, BacterialPhase 2NAVAP-ECMONCT06602557
" 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 "
A Phase 2 study testing Amikacin in people with Pneumonia, Bacterial and Extracorporeal Membrane Oxygenation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial, Extracorporeal Membrane Oxygenation
- What is being tested?
- Amikacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 10 Aug 2026to 10 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Known allergy to amikacin or another aminoglycoside or to an auxiliary drug or to any of their excipients.
- Contraindication to the administration of amikacin or its excipients listed in the summary of product characteristics.
- Contraindication to the administration of an auxiliary drug or to one of its excipients listed in the summary of product characteristics.
- Contraindications to nebulization
- Intravenous antibiotic therapy started more than 72 hours before randomization
- Probabilistic venous antibiotic therapy other than piperacillin - tazobactam
Show all 13Show fewer
- Administration of inhaled antibiotics within 7 days prior to inclusion
- Positive pregnancy test for women of childbearing potential
- Presence of HIV infection with CD4 count inferior to 200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema
- 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.
- Patent moribund (SAPS II superior to 75) or 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, 75013
Pauline DUREAU, MD, PhD, +33 1 84 82 76 89, pauline.dureau@aphp.fr
About this study
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.
- Being tested
- Amikacin, Standard of care
- Keywords
- ECMO, Hospital acquired pneumonia, Antibiotic nebulization, Pharmacokinetic
- Medical subject headings
- Pneumonia, Bacterial, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
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.
Standard of careDrug
Patients included in the standard of care group will not receive any nebulization. They will receive Standard care alone.
| Study group | Role | What they receive |
|---|---|---|
| Amikacine nebulization associated with Standard of care | Experimental | Not described Receives: Drug: Amikacin |
| Standard of care | Active comparator | Not described Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial eradication rate
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.
Measured: Day 5
Secondary outcomes (9)
Clinical cure rate
Clinical cure rate, defined as disappearance of clinical signs suggestive of pneumonia, biological inflammatory syndrome and correction of haematosis disorders, at D5.
Measured: Day 5
Pneumonia persistence rate
Pneumonia persistence rate defined as the presence of the pathogen identified at a significant level on culture of tracheal aspirate at D5.
Measured: Day 5
Change in clinical pulmonary infection score (CPIS)
Difference between CPIS score at D5 and CPIS score at randomization.
Measured: Day 0 to Day 5
Change in pulmonary aeration score
Difference between ultrasound pulmonary aeration score at D5 and pulmonary aeration score at randomization.
Measured: Day 0 to Day 5
Adverse events
Quantifying and analysing adverse events and serious adverse events
Measured: Day 0 to Day 5
Pharmacokinetic analysis of piperacillin tazobactam
Pharmacokinetic analysis of plasma concentrations of the piperacillin - tazobactam combination
Measured: Day 1
Alveolar fluid penetration ratio of piperacillin-tazobactam
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
Measured: Day 1
Pharmacokinetic analysis of Amikacin
Measurement of the plasma concentration of Amikacin in patients on ECMO-VA in the treatment group between D1 and D5.
Measured: Day 1 to Day 5
Alveolar fluid concentration of Amikacin
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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Aug 2026
- Primary completion10 Aug 2028 (estimated)
- Study completion10 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602557
- Sponsor's protocol ID
- NAVAP-ECMO
- Acronym
- NAVAP-ECMO
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " 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 "
- ClinicalTrials.gov ID
- NCT06602557
- Acronym / sponsor ID
- NAVAP-ECMO / NAVAP-ECMO
- Keywords
- ECMO, Hospital acquired pneumonia, Antibiotic nebulization, Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 10 Feb 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amikacine nebulization associated with Standard of care | Experimental | Drug: Amikacin |
| Standard of care | Active comparator | Drug: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- Known allergy to amikacin or another aminoglycoside or to an auxiliary drug or to any of their excipients.
- Contraindication to the administration of amikacin or its excipients listed in the summary of product characteristics.
- Contraindication to the administration of an auxiliary drug or to one of its excipients listed in the summary of product characteristics.
- Contraindications to nebulization
- Intravenous antibiotic therapy started more than 72 hours before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmikacinPatients 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. | Drug | Amikacine nebulization associated with Standard of care |
| Standard of carePatients included in the standard of care group will not receive any nebulization. They will receive Standard care alone. | Drug | Standard of care |
Primary outcome
Bacterial eradication rate
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.
9 secondary outcomes
Clinical cure rate
Time frame: Day 5
Pneumonia persistence rate
Time frame: Day 5
Change in clinical pulmonary infection score (CPIS)
Time frame: Day 0 to Day 5
Change in pulmonary aeration score
Time frame: Day 0 to Day 5
Adverse events
Time frame: Day 0 to Day 5
Pharmacokinetic analysis of piperacillin tazobactam
Time frame: Day 1
Alveolar fluid penetration ratio of piperacillin-tazobactam
Time frame: Day 1
Pharmacokinetic analysis of Amikacin
Time frame: Day 1 to Day 5
Alveolar fluid concentration of Amikacin
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amikacin in people with Pneumonia, Bacterial and Extracorporeal Membrane Oxygenation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline DUREAU, MD, PhD (01 84 82 76 89, pauline.dureau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial eradication rate (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.