Ventilator-Associated PneumoniaPhase 3AMIVATNCT07665788
Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis
A Phase 3 study testing Optimized and protocolized nebulization procedure. in people with Ventilator-Associated Pneumonia and Ventilator-Associated Tracheobronchitis, run by University Hospital, Tours at 17 sites in France.
Trial summary
The primary objective of the AMIVAT trial is to assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the incidence of progression to ventilator-associated pneumonia (VAP) at day 28 in intensive care unit (ICU) patients with ventilator-associated tracheobronchitis (VAT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Pneumonia, Ventilator-Associated Tracheobronchitis
- What is being tested?
- Optimized and protocolized nebulization procedure.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 17 sitesFrance
- Study dates
- 1 Jun 2026to 1 Sep 2029
- Phase
- Phase 3
- 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
- Age ≥ 18 years
- Admission to a participating intensive care unit (ICU)
- Invasive mechanical ventilation > 48 hours
- First episode of ventilator-associated tracheobronchitis during the ICU stay defined using the following criteria: (i) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate ≥10.5 colony-forming unit (CFU)/mL or on bronchoalveolar lavage ≥10.4 CFU/mL or on plugging telescopic catheter ≥10.3 CFU/mL
- Coverage by the French health insurance system (Social Security)
- Written informed consent obtained from the patient, or, if the patient is not able to give written consent, from his or her legally designated representative (trusted person designated by the patient or, failing that, a family member) or, failing that, inclusion performed by the investigator within the therapeutic window (in such cases, informed consent will be sought by the investigator from the patient, or his or her legally designated representative, whichever is sooner). In all cases, the patient's written informed consent will be obtained as soon as possible.
- For woman of childbearing potential: negative pregnancy test result at the time of inclusion
Who cannot join
- Previous ventilator-associated pneumonia due to the pathogens responsible for ventilator-associated tracheobronchitis during the same ICU stay
- On-going antimicrobial therapy fpr ventilator-associated pneumonia
- Ventilator-associated tracheobronchitis due to pathogens with intrinsic amikacin resistance (e.g. Stenotrophomonas maltophilia)
- On-going therapy with intravenous amikacin or another aminoglycoside
- Acute kidney injury stage 2 or 3 of the Kidney Disease Improving Global Outcomes (KDIGO) classification and/or advanced chronic kidney failure (glomerular filtration rate <30 mL/min), except in patients under renal replacement therapy
- Grade B or C cirrhosis (Child-Pugh classification)
Show all 20Show fewer
- Scheduled extubation within 24h
- Prior tracheotomy
- Administration of inhaled antibiotics within the 7 preceding days
- Known hypersensitivity to amikacin, another aminoglycoside, or any of the excipients
- Myasthenia gravis
- Contraindication to nebulization
- On-going treatment with ataluren
- Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship).
- Moribund patient
- End-of-life decision
- Previous inclusion in the present study
- Participation to another interventional study
- Inability of the patient, or the person providing consent, to understand all aspects of the research
- Patient being a relative of the investigator or a relative of someone from the team directly involved in the trial, including doctors and pharmacists
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites
06 - ANGERS - Intensive care, University Hospital
Angers, 49933
Tchamba Achille KOUATCHET, 02 41 35 38 15, AcKouatchet@chu-angers.fr
Tchamba Achille KOUATCHET
04 - ARGENTEUIL - Intensive care, University Hospital
Argenteuil
Gaëtan PLANTEFEVE, 01 34 23 14 45, gaetan.plantefeve@ch-argenteuil.fr
Gaëtan PLANTEFEVE
11 - BLOIS, Intensive care, Hospital
Blois
Julien GROUILLE, 02 54 55 60 73, grouilj@ch-blois.fr
Julien GROUILLE
09 - BOURG-EN-BRESSE, Intensive care, Hospital
Bourg-en-Bresse, 01012
Adrien ROBINE, 04 74 45 46 47, arobine@ch-bourg01.fr
Adrien ROBINE
10 - HENRI MONDOR, Intensive care, University Hospital
Créteil, 94010
Pierre BAY, 01 49 81 23 89, pierre.bay@aphp.fr
Pierre BAY
07 - DIEPPE - Intensive care, University Hospital
Dieppe, 76202
Pierre-Louis DECLERCQ, 02 32 14 76 76, Pdeclercq@ch-dieppe.fr
Pierre-Louis DECLERCQ
08 - DIJON - Intensive care, University Hospital
Dijon, 21000
Jean-Pierre QUENOT, 03 80 29 37 51, jean-pierre.quenot@chu-dijon.fr
Jean-Pierre QUENOT
12 - DREUX, Intensive care, Hospital
Dreux, 28100
14 - VERSAILLES, Intensive care, Hospital
Le Chesnay, 78150
Alexis FERRE, 01 39 63 87 00, aferre@ght78sud.fr
Alexis FERRE
05 - LE MANS - Intensive care, University Hospital
Le Mans, 72037
Mickael LANDAIS, MD, 02 43 43 24 58, mlandais@ch-lemans.fr
Mickaël LANDAIS
15 - LYON EH, Intensive care, University Hospital
Lyon, 69437
Laurent ARGAUD, 04 72 11 28 62, laurent.argaud@chu-lyon.fr
Laurent ARGAUD
01 - ORLEANS - Intensive care, University Hospital
Orléans, 45000
François BARBIER, 02 38 22 99 39, francois.barbier@chu-orleans.fr
François BARBIER
17 - LOUIS MOURIER, Intensive care, University Hospital
Paris, 32700
Damien ROUX, 01 47 60 68 33, damien.roux@aphp.fr
Damien ROUX
13 - BICHAT, Intensive care, Univerity Hospital
Paris
Jean-François TIMSIT, 01 40 25 77 03, jean-francois.timsit@aphp.fr
Jean-François TIMSIT
16 - LYON SUD, Intensive care, University Hospital
Pierre-Bénite, 69495
Donatien DE MARIGNAN, 04 78 86 21 19, donatien.de-marignan@chu-lyon.fr
Donatien DE MARIGNAN
03 - STRASBOURG - Intensive care, University Hospital
Strasbourg, 67091
Julien DEMISELLE, 03 69 55 10 19, julien.demiselle@chru-strasbourg.fr
Julien DEMISELLE
02 - TOURS - Intensive care, University Hospital
Tours, 37044
Stephan EHRMANN, 02 47 47 98 51, stephan.ehrmann@univ-tours.fr
Stephan EHRMANN
About this study
Official title: A Multicentre, Double-blind, Randomized Controlled Trial of Inhaled Amikacin Versus Placebo in Critically Ill Patients With Ventilator-associated Tracheobronchitis
The primary objective of the AMIVAT trial is to assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the incidence of progression to ventilator-associated pneumonia (VAP) at day 28 in intensive care unit (ICU) patients with ventilator-associated tracheobronchitis (VAT). Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT.
Read the detailed description
VAT will be defined using the following criteria: (i) duration of mechanical ventilation > 48 hours, (ii) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate (ETA) ≥10.5 colony-forming unit (CFU)/mL or on bronchoalveolar lavage ≥10.4 CFU/mL or on plugging telescopic catheter ≥10.3 CFU/mL. Inclusion and randomization will be performed after written informed consent, as soon as inclusion criteria are met, within 24 hours after VAT suspicion (ETA sampling) whenever possible. Patients in the experimental group will receive inhaled amikacin (once daily, 20 mg/kg of predicted body weight with a maximum of 2 grams) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer). Patients in the control group will receive inhaled placebo (NaCl 0.9%, once daily) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer). Nebulization will be performed according to a standardized procedure using a vibrating mesh nebulizer (Aerogen Solo, Aerogen, Galway, Ireland). A bedside checklist will be used to ensure optimal implementation practice. All staff involved in nebulization will be trained prior to their study involvement. The systemic diffusion and pharmacokinetics of inhaled amikacin will be assessed through measurement of peak and residual blood concentrations in a pre-planned subsample of patients. Study treatment will be discontinued before the 5th administration in the following cases: (i) documented acquired amikacin resistance in at least one pathogen responsible for VAT, (ii) occurrence of VAP before Day 5, (iii) occurrence of AKI stage 2 or 3 of the KDIGO classification before Day 5 (except for patients receiving renal replacement therapy), (iv) clinical indication for mandatory IV aminoglycoside therapy (amikacin, gentamicin, tobramycin) before Day 5, (v) extubation before Day 5, (vi) unexpected SAE deemed related to the IP and/or a patient's clinical condition that requires suspension of the treatment according to the local investigator. Patients will be followed-up until Day 28 for the primary study endpoint and up to Day 90 for certain secondary study endpoints (Day-90 mortality, and day-90 health-related quality of life [HRQoL] in survivors).
- Being tested
- Optimized and protocolized nebulization procedure.
- Keywords
- Ventilator-associated tracheobronchitis, Ventilator-associated pneumonia, Inhaled antimicrobial therapy, Mechanical ventilation, Hospital-acquired infection, Ventilator-associated lower respiratory tract infection, ICU-acquired infection, Aminoglycoside, Amikacin
- Medical subject headings
- Pneumonia, Ventilator-Associated, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized and protocolized nebulization procedure.Drug
Patients in the experimental group will receive inhaled amikacin (once daily, 20 mg/kg of predicted body weight with a maximum of 2 grams) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer).
Optimized and protocolized nebulization procedure.Drug
Patients in the control group will receive inhaled placebo (NaCl 0.9%, once daily) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer).
| Study group | Role | What they receive |
|---|---|---|
| Inhaled amikacin | Experimental | Not described Receives: Drug: Optimized and protocolized nebulization procedure. |
| Inhaled NaCl 0.9% | Placebo comparator | Not described Receives: Drug: Optimized and protocolized nebulization procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 28
Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT
Measured: From randomization to day 28
Secondary outcomes (20)
Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 7
Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT
Measured: From randomization to day 7
Overall incidence of a first ventilator-associated pneumonia episode (all pathogens) at day 28
Measured: From randomization to day 28
Overall incidence of a first ventilator-associated pneumonia episode due to multidrug-resistant bacteria at day 28
Measured: From randomization to day 28
Time to resolution of clinical signs of ventilator-associated tracheobronchitis
Purulent tracheal aspirates, plus leukocytosis or leukopenia and/or fever or hypothermia if present at randomization
Measured: From randomization to day 28
Proportion of patients with persistence of the pathogens responsible for ventilator-associated tracheobronchitis on endotracheal aspirate at day 7
Measured: Day 7
Total duration of mechanical ventilation
Number of days with mechanical ventilation
Measured: From randomization to day 90
Number of ventilator-free days at day 28
Measured: From randomization to day 28
The number of days with systemic antibiotics at Day 28
i.e., intravenous and/or enteral administration
Measured: From randomization to day 28
Number of defined daily doses of systemic antibiotics at day 28
i.e., intravenous and/or enteral administration
Measured: From randomization to day 28
Incidence of intensive care unit-acquired intestinal colonization with multidrug-resistant bacteria at day 28
Measured: From randomization to day 28
Overall incidence of Intensive care unit-acquired infection due to multidrug-resistant bacteria at day 28
Measured: From randomization to day 28
Lenght of stay in the intensive care unit
Measured: From randomization to day 90
Lenght of hospital stay
Measured: From randomization to day 90
All-cause mortality at day 28
Measured: From randomization to day 28
All-cause mortality at day 90
Measured: From randomization to day 90
Health-related quality of life at day 90
EuroQuol-5 Dimensions-5 Levels standardised questionnaire (5Q-5D-5L). Health state will be converted into a utility values using the appropriate weight in each country. Health state EQ-5D values range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Measured: Day 90
Incidence of acute kidney injury at day 28
Safety analysis
Measured: From randomization to day 28
Occurrence of respiratory adverse events related to amikacin nebulization
Safety analysis
Measured: From randomization to day 90
Peak serum amikacin concentration 1 hour after inhaled study-drug nebulization
Pre-planned subsample. Blood samples will be collected in 50 selected patients, 25 per arm to preserve blinding For each patient included in this substudy, one sample will be collected 1 hour after the preceding nebulization to measure the peak serum amikacin concentration.
Measured: At Day 1, Day 3 and Day 5.
Trough serum amikacin concentration 24 hours after inhaled study-drug nebulization.
Blood samples will be collected in 50 selected patients, 25 per arm to preserve blinding. For each patient included in this substudy, two samples will be collected 24 hours after the preceding nebulization to measure trough serum amikacin concentrations, for a total of 3 samples per patient.
Measured: At Day 1, Day 3 and Day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Aerogen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665788
- Sponsor's protocol ID
- DR230005
- Other IDs
- 2023-510075-63-00, 2023
- Acronym
- AMIVAT
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-blind, Randomized Controlled Trial of Inhaled Amikacin Versus Placebo in Critically Ill Patients With Ventilator-associated Tracheobronchitis
- ClinicalTrials.gov ID
- NCT07665788
- Acronym / sponsor ID
- AMIVAT / DR230005
- Keywords
- Ventilator-associated tracheobronchitis, Ventilator-associated pneumonia, Inhaled antimicrobial therapy, Mechanical ventilation, Hospital-acquired infection, Ventilator-associated lower respiratory tract infection, ICU-acquired infection, Aminoglycoside
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Aerogen
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 24 Jun 2026 (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.
The primary objective of the AMIVAT trial is to assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the incidence of progression to ventilator-associated pneumonia (VAP) at day 28 in intensive care unit (ICU) patients with ventilator-associated tracheobronchitis (VAT). Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT.
Detailed description
VAT will be defined using the following criteria: (i) duration of mechanical ventilation > 48 hours, (ii) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate (ETA) ≥10.5 colony-forming unit (CFU)/mL or on bronchoalveolar lavage ≥10.4 CFU/mL or on plugging telescopic catheter ≥10.3 CFU/mL. Inclusion and randomization will be performed after written informed consent, as soon as inclusion criteria are met, within 24 hours after VAT suspicion (ETA sampling) whenever possible. Patients in the experimental group will receive inhaled amikacin (once daily, 20 mg/kg of predicted body weight with a maximum of 2 grams) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer). Patients in the control group will receive inhaled placebo (NaCl 0.9%, once daily) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer). Nebulization will be performed according to a standardized procedure using a vibrating mesh nebulizer (Aerogen Solo, Aerogen, Galway, Ireland). A bedside checklist will be used to ensure optimal implementation practice. All staff involved in nebulization will be trained prior to their study involvement. The systemic diffusion and pharmacokinetics of inhaled amikacin will be assessed through measurement of peak and residual blood concentrations in a pre-planned subsample of patients. Study treatment will be discontinued before the 5th administration in the following cases: (i) documented acquired amikacin resistance in at least one pathogen responsible for VAT, (ii) occurrence of VAP before Day 5, (iii) occurrence of AKI stage 2 or 3 of the KDIGO classification before Day 5 (except for patients receiving renal replacement therapy), (iv) clinical indication for mandatory IV aminoglycoside therapy (amikacin, gentamicin, tobramycin) before Day 5, (v) extubation before Day 5, (vi) unexpected SAE deemed related to the IP and/or a patient's clinical condition that requires suspension of the treatment according to the local investigator. Patients will be followed-up until Day 28 for the primary study endpoint and up to Day 90 for certain secondary study endpoints (Day-90 mortality, and day-90 health-related quality of life [HRQoL] in survivors).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled amikacin | Experimental | Drug: Optimized and protocolized nebulization procedure. |
| Inhaled NaCl 0.9% | Placebo comparator | Drug: Optimized and protocolized nebulization procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Admission to a participating intensive care unit (ICU)
- Invasive mechanical ventilation > 48 hours
- First episode of ventilator-associated tracheobronchitis during the ICU stay defined using the following criteria: (i) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate ≥10.5 colony-forming unit (CFU)/mL or on bronchoalveolar lavage ≥10.4 CFU/mL or on plugging telescopic catheter ≥10.3 CFU/mL
- Coverage by the French health insurance system (Social Security)
Key exclusion criteria (20 listed)
- Previous ventilator-associated pneumonia due to the pathogens responsible for ventilator-associated tracheobronchitis during the same ICU stay
- On-going antimicrobial therapy fpr ventilator-associated pneumonia
- Ventilator-associated tracheobronchitis due to pathogens with intrinsic amikacin resistance (e.g. Stenotrophomonas maltophilia)
- On-going therapy with intravenous amikacin or another aminoglycoside
- Acute kidney injury stage 2 or 3 of the Kidney Disease Improving Global Outcomes (KDIGO) classification and/or advanced chronic kidney failure (glomerular filtration rate <30 mL/min), except in patients under renal replacement therapy
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 |
|---|---|---|
| Optimized and protocolized nebulization procedure.Patients in the experimental group will receive inhaled amikacin (once daily, 20 mg/kg of predicted body weight with a maximum of 2 grams) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer). | Drug | Inhaled amikacin |
| Optimized and protocolized nebulization procedure.Patients in the control group will receive inhaled placebo (NaCl 0.9%, once daily) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer). | Drug | Inhaled NaCl 0.9% |
Primary outcome
Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 28
Time frame: From randomization to day 28
Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT
20 secondary outcomes
Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 7
Time frame: From randomization to day 7
Overall incidence of a first ventilator-associated pneumonia episode (all pathogens) at day 28
Time frame: From randomization to day 28
Overall incidence of a first ventilator-associated pneumonia episode due to multidrug-resistant bacteria at day 28
Time frame: From randomization to day 28
Time to resolution of clinical signs of ventilator-associated tracheobronchitis
Time frame: From randomization to day 28
Proportion of patients with persistence of the pathogens responsible for ventilator-associated tracheobronchitis on endotracheal aspirate at day 7
Time frame: Day 7
Total duration of mechanical ventilation
Time frame: From randomization to day 90
Number of ventilator-free days at day 28
Time frame: From randomization to day 28
The number of days with systemic antibiotics at Day 28
Time frame: From randomization to day 28
Number of defined daily doses of systemic antibiotics at day 28
Time frame: From randomization to day 28
Incidence of intensive care unit-acquired intestinal colonization with multidrug-resistant bacteria at day 28
Time frame: From randomization to day 28
Overall incidence of Intensive care unit-acquired infection due to multidrug-resistant bacteria at day 28
Time frame: From randomization to day 28
Lenght of stay in the intensive care unit
Time frame: From randomization to day 90
Lenght of hospital stay
Time frame: From randomization to day 90
All-cause mortality at day 28
Time frame: From randomization to day 28
All-cause mortality at day 90
Time frame: From randomization to day 90
Health-related quality of life at day 90
Time frame: Day 90
Incidence of acute kidney injury at day 28
Time frame: From randomization to day 28
Occurrence of respiratory adverse events related to amikacin nebulization
Time frame: From randomization to day 90
Peak serum amikacin concentration 1 hour after inhaled study-drug nebulization
Time frame: At Day 1, Day 3 and Day 5.
Trough serum amikacin concentration 24 hours after inhaled study-drug nebulization.
Time frame: At Day 1, Day 3 and Day 5.
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 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Optimized and protocolized nebulization procedure. in people with Ventilator-Associated Pneumonia and Ventilator-Associated Tracheobronchitis, run by University Hospital, Tours at 17 sites 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 7 inclusion and 20 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 François BARBIER, PU-PH (02 38 22 99 39, francois.barbier@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 28 (time frame: From randomization to day 28). 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 24 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.