Ventilator Associated Bacterial PneumoniaPhase 3PYOPHANEBNCT07804082
A Double-Blind, Placebo-Controlled Study of Nebulized Bacteriophages in Patients With Ventilator-Associated Pneumonia Due to Pseudomonas Aeruginosa
A Phase 3 study testing Bacteriophages GMP in people with Ventilator Associated Bacterial Pneumonia and Pseudomonas Aeruginosa Infection, run by Assistance Publique - Hôpitaux de Paris at 16 sites in France.
Trial summary
Ventilator-associated pneumonia (VAP) complicates the hospital course of up to 40% of mechanically ventilated patients and is associated with mortality rates approaching 30%, despite appropriate antibiotic therapy (ATB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Bacterial Pneumonia, Pseudomonas Aeruginosa Infection
- What is being tested?
- Bacteriophages GMP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 16 sitesFrance
- Study dates
- 3 Nov 2026to 3 Jan 2030
- 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
- Patients ≥ 18 years old
- Intubated and mechanically ventilated for at least 48 hours
- Mechanical ventilation expected to continue for at least 3 days
- Clinical diagnosis of VAP
- VAP due to P. aeruginosa (P. aeruginosa recovered at a significant level from lung sample (≥10^4/ml for BAL or ≥10^5/ml for tracheal aspirate or ≥10^3 CFU/ml for plugged telescopic catheter)
- Signed informed consent from the patient or the patient's legal representative or a family member or a close relative. According to the legal conditions of emergency inclusion, randomization without the family member or the surrogate consent could be performed if the patient is unable to give his/her consent and if no legal representative/family member or close relative is present. Close relative/ legal representative/family member consent will be asked as soon as possible. The patient will be asked to give his/her consent for continuation of the trial when his/her condition will allow.
- Patient with childbearing potential* should have reliable contraception for the all duration of the study
- Affiliation to social security (AME excluded)
Who cannot join
- Severe hypoxemia as defined by PaO2/FiO2 < 100 mmHg, except if the patient is on ECMO (extracorporeal membrane oxygenation)
- Impossibility to set a tidal volume of 6 ml/kg of ideal body weight during nebulization without risk of barotrauma
- Patients with cystic fibrosis, lung cancer, lung resection, known bronchial obstruction, or active tuberculosis
- Patient not expecting to survive 48 hours after randomization
- Polymicrobial VAP (presence of pathogens other than P. aeruginosa at a significant level in lung samples (≥10^4/ml for BAL or ≥10^5/ml for tracheal aspirate). If the culture retrieves oropharyngeal flora, even at a significant threshold, in addition to Pseudomonas aeruginosa, the patient is eligible.
- Contraindication to nebulization
Show all 9Show fewer
- Participation in another interventional study evaluating drugs for VAP or being in the exclusion period following the end of a previous interventional study evaluating drugs for VAP
- Pregnancy or breastfeeding
- Patients under guardianship or curatorship
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites
CHU Amiens
Amiens, 80054
Yazine MAHJOUB, MD
CHU Amiens
Amiens, 80054
Stéphanie MALAQUIN, MD
CHU Angers
Angers, 49933
Pierre ASFAR, MD
Hôpital Avicenne
Bobigny, 93000
Antoine MONSEL, MD
Hôpital Avicenne
Bobigny, 93000
Sophie NAGLE, MD
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Renaud GUERIN, MD
Hôpital Louis Mourier
Colombes, 92700
Baptiste GABORIEU, MD
Hôpital Henri Mondor
Créteil, 94000
Pierre BAY, MD
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Nadia ANGUEL, MD
CHU Nice
Nice, 06200
Mathieu JOZWIAK, MD
CHU Orléans
Orléans, 45000
François BARBIER, MD
Hôpital Pitié-Salpêtrière
Paris, 75013
Charles-Edouard LUYT, MD
Hôpital Pitié-Salpêtrière
Paris, 75013
Adrien BOUGLE, MD
Hôpital Pitié-Salpêtrière
Paris, 75013
Julien MAYAUX, MD
Hôpital Pitié-Salpêtrière
Paris, 75013
Florian BLANCHARD, MD
Hôpital Pitié-Salpêtrière
Paris, 75013
Alexandre BLEIBTREU, MD
About this study
Ventilator-associated pneumonia (VAP) complicates the hospital course of up to 40% of mechanically ventilated patients and is associated with mortality rates approaching 30%, despite appropriate antibiotic therapy (ATB). Gram-negative bacteria account for approximately 60% of VAP episodes, with Pseudomonas aeruginosa (Pa) being one of the most common pathogens. Recurrent Pa-VAP occurs in 19-33% of cases outside the COVID-19 setting, whereas recurrence rates as high as 79% have been reported in patients with COVID-19, most often caused by the same pathogen and frequently occurring despite adequate antibiotic therapy.
Several attempts have been made to improve pulmonary antibiotic exposure by combining intravenous therapy with aerosolized antibiotics delivered through conventional nebulizers. However, clinical results have been disappointing, largely because standard jet nebulizers deliver less than 10% of the nominal dose to the lungs owing to high residual volumes, drug deposition within the ventilator circuit and endotracheal tube, and loss through the expiratory limb. Even with more efficient vibrating mesh nebulizers, two recent randomized con-trolled trials failed to demonstrate any clinical benefit of adjunctive nebulized antibiotics in patients with Gram-negative VAP.
Read more
Bacteriophages are bacteria-specific viruses that have emerged as a promising therapeutic alternative for difficult-to-treat bacterial infections. Their highly specific host range allows selective targeting of pathogenic bacteria while sparing the commensal microbiota and human cells, thereby minimizing toxicity and off-target effects. An increasing body of preclinical evidence and clinical case reports supports the safety and potential efficacy of anti-P. aeruginosa phage therapy. More recently, a porcine model of Pa-VAP demonstrated that high concentrations of bacteriophages can be efficiently delivered to the lungs by nebulization during mechanical ventilation, resulting in rapid control of the pulmonary infection. The use of phages as compassionate treatment has been authorized in September 2021 in this indication using phages produced by Phagenix- ©.
The aim of this placebo controlled study is to demonstrate the efficacy and safety of nebulized anti-Pa bacteriophages, delivered to the lung using a vi-brating mesh nebulizer, in addition to conventional IV ATB treatment.
- Being tested
- Bacteriophages GMP, saline solution (placebo)
- Keywords
- Nebulized Bacteriophages, Ventilator Associated Bacterial Pneumonia
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophages GMPBiological
Five administrations of phages daily from D1 to D5
saline solution (placebo)Drug
Five administrations of saline solution daily from D1 to D5
| Study group | Role | What they receive |
|---|---|---|
| Bacteriophages GMP | Experimental | Nebulization of bacteriophages PP1450, PP1777, PP1792 and PP1797 will be performed using a vibrating mesh nebulizer (Aerogen). The aerosol generator will be placed upstream of the heated humidifier, which will remain active during administration. The nebulizer chamber will be filled immediately prior to dosing. When clinically feasible, mechanical ventilation settings will be standardized (volume-controlled mode, tidal volume 6-8 mL/kg ideal body weight, respiratory rate 16-20/min, inspiratory flow <40 L/min), with no specific adjustments for PEEP or FiO₂. Sedation may be used to minimize patient-ventilator asynchrony. Nebulization is expected to last approximately 45-60 minutes. These settings are recommended but not mandatory. Receives: Biological: Bacteriophages GMP |
| Saline solution | Placebo comparator | Nebulization of saline solution will be performed using a vibrating mesh nebulizer (Aerogen). The aerosol generator will be placed upstream of the heated humidifier, which will remain active during administration. The nebulizer chamber will be filled immediately prior to dosing. When clinically feasible, mechanical ventilation settings will be standardized (volume-controlled mode, tidal volume 6-8 mL/kg ideal body weight, respiratory rate 16-20/min, inspiratory flow <40 L/min), with no specific adjustments for PEEP or FiO₂. Sedation may be used to minimize patient-ventilator asynchrony. Nebulization is expected to last approximately 45-60 minutes. These settings are recommended but not mandatory. Receives: Drug: saline solution (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive and cured at D28 and without any recurrence of Pa-VAP between the initial episode and D28.
Cure is defined as :
- Resolution of signs and symptoms of infection
- Improvement of PaO2/FiO2 ratio as compared to value the day VAP is diagnosed
- No appearance of new signs of sepsis All 3 criteria must be fulfilled 7 to 10 days after antibiotic initiation
Recurrence is defined as:
-a clinically suspected VAP (fever, radiological opacity, increase in ventilation need)
A microbiological confirmation with Pa recovered at a significant level from lung sample (≥10^4/ml for BAL or ≥10^5/ml for tracheal aspirate or ≥ 10^3 CFU/mL for plugged telescopic catheter).
Measured: Day 28
Secondary outcomes (11)
Resolution of ventilator-associated pneumonia symptoms
Measured: Day 7 +/- 3 days
Incidence of new ventilator-associated pneumonia
Measured: Day 7 +/- 3 days and day 14
Clinical improvement, defined by a modified Clinical pulmonary infection score <4 (range 0-12, with higher score indicating worse outcome) and no new Pseudomonas aeruginosa ventilator-associated pneumonia episode
Measured: Day 14
Incidence of Pseudomonas aeruginosa detection in respiratory samples
Measured: Day 3, Day 5, Day 7, Day 10, Day 14 and Day 28
Number of days alive
Measured: Day 28
Number of day without invasive mechanical ventilation
Measured: Day 28
Number of day without antibiotics
Measured: Day 28
Anti-phage antibody presence and titers,
Measured: Day 1, 7, 10, 14 and 28
Phage neutralization titers
Measured: Day 1, 7, 10, 14 and 28
Mortality rate
Measured: Day 28 and Day 60
Prevalence of ESBL-producing and carbapenem-resistant Gram-negative bacteria in fecal and tracheal aspirate samples
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start3 Nov 2026 (estimated)
- Primary completion3 Dec 2029 (estimated)
- Study completion3 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Bacterial PneumoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, 2 parallel arms, double-blind, randomised (1:1) superiority trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 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
- NCT07804082
- Sponsor's protocol ID
- APHP222819
- Other IDs
- 2024-514008-15
- Acronym
- PYOPHANEB
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Nebulized Bacteriophages in Patients With Ventilator-Associated Pneumonia Due to Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT07804082
- Acronym / sponsor ID
- PYOPHANEB / APHP222819
- Keywords
- Nebulized Bacteriophages, Ventilator Associated Bacterial Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 3 Dec 2029 (estimated)
- Study completion
- 3 Jan 2030 (estimated)
- First posted
- 4 Sep 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.
Ventilator-associated pneumonia (VAP) complicates the hospital course of up to 40% of mechanically ventilated patients and is associated with mortality rates approaching 30%, despite appropriate antibiotic therapy (ATB). Gram-negative bacteria account for approximately 60% of VAP episodes, with Pseudomonas aeruginosa (Pa) being one of the most common pathogens. Recurrent Pa-VAP occurs in 19-33% of cases outside the COVID-19 setting, whereas recurrence rates as high as 79% have been reported in patients with COVID-19, most often caused by the same pathogen and frequently occurring despite adequate antibiotic therapy.
Several attempts have been made to improve pulmonary antibiotic exposure by combining intravenous therapy with aerosolized antibiotics delivered through conventional nebulizers. However, clinical results have been disappointing, largely because standard jet nebulizers deliver less than 10% of the nominal dose to the lungs owing to high residual volumes, drug deposition within the ventilator circuit and endotracheal tube, and loss through the expiratory limb. Even with more efficient vibrating mesh nebulizers, two recent randomized con-trolled trials failed to demonstrate any clinical benefit of adjunctive nebulized antibiotics in patients with Gram-negative VAP.
Bacteriophages are bacteria-specific viruses that have emerged as a promising therapeutic alternative for difficult-to-treat bacterial infections. Their highly specific host range allows selective targeting of pathogenic bacteria while sparing the commensal microbiota and human cells, thereby minimizing toxicity and off-target effects. An increasing body of preclinical evidence and clinical case reports supports the safety and potential efficacy of anti-P. aeruginosa phage therapy. More recently, a porcine model of Pa-VAP demonstrated that high concentrations of bacteriophages can be efficiently delivered to the lungs by nebulization during mechanical ventilation, resulting in rapid control of the pulmonary infection. The use of phages as compassionate treatment has been authorized in September 2021 in this indication using phages produced by Phagenix- ©.
The aim of this placebo controlled study is to demonstrate the efficacy and safety of nebulized anti-Pa bacteriophages, delivered to the lung using a vi-brating mesh nebulizer, in addition to conventional IV ATB treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multicenter, 2 parallel arms, double-blind, randomised (1:1) superiority trial
| Arm | Type | Receives |
|---|---|---|
| Bacteriophages GMP | Experimental | Biological: Bacteriophages GMPNebulization of bacteriophages PP1450, PP1777, PP1792 and PP1797 will be performed using a vibrating mesh nebulizer (Aerogen). The aerosol generator will be placed upstream of the heated humidifier, which will remain active during administration. The nebulizer chamber will be filled immediately prior to dosing. When clinically feasible, mechanical ventilation settings will be standardized (volume-controlled mode, tidal volume 6-8 mL/kg ideal body weight, respiratory rate 16-20/min, inspiratory flow <40 L/min), with no specific adjustments for PEEP or FiO₂. Sedation may be used to minimize patient-ventilator asynchrony. Nebulization is expected to last approximately 45-60 minutes. These settings are recommended but not mandatory. |
| Saline solution | Placebo comparator | Drug: saline solution (placebo)Nebulization of saline solution will be performed using a vibrating mesh nebulizer (Aerogen). The aerosol generator will be placed upstream of the heated humidifier, which will remain active during administration. The nebulizer chamber will be filled immediately prior to dosing. When clinically feasible, mechanical ventilation settings will be standardized (volume-controlled mode, tidal volume 6-8 mL/kg ideal body weight, respiratory rate 16-20/min, inspiratory flow <40 L/min), with no specific adjustments for PEEP or FiO₂. Sedation may be used to minimize patient-ventilator asynchrony. Nebulization is expected to last approximately 45-60 minutes. These settings are recommended but not mandatory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years old
- Intubated and mechanically ventilated for at least 48 hours
- Mechanical ventilation expected to continue for at least 3 days
- Clinical diagnosis of VAP
- VAP due to P. aeruginosa (P. aeruginosa recovered at a significant level from lung sample (≥10^4/ml for BAL or ≥10^5/ml for tracheal aspirate or ≥10^3 CFU/ml for plugged telescopic catheter)
Key exclusion criteria (9 listed)
- Severe hypoxemia as defined by PaO2/FiO2 < 100 mmHg, except if the patient is on ECMO (extracorporeal membrane oxygenation)
- Impossibility to set a tidal volume of 6 ml/kg of ideal body weight during nebulization without risk of barotrauma
- Patients with cystic fibrosis, lung cancer, lung resection, known bronchial obstruction, or active tuberculosis
- Patient not expecting to survive 48 hours after randomization
- Polymicrobial VAP (presence of pathogens other than P. aeruginosa at a significant level in lung samples (≥10^4/ml for BAL or ≥10^5/ml for tracheal aspirate). If the culture retrieves oropharyngeal flora, even at a significant threshold, in addition to Pseudomonas aeruginosa, the patient is eligible.
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 |
|---|---|---|
| Bacteriophages GMPFive administrations of phages daily from D1 to D5 | Biological | Bacteriophages GMP |
| saline solution (placebo)Five administrations of saline solution daily from D1 to D5 | Drug | Saline solution |
Primary outcome
Proportion of patients alive and cured at D28 and without any recurrence of Pa-VAP between the initial episode and D28.
Time frame: Day 28
Cure is defined as : * Resolution of signs and symptoms of infection * Improvement of PaO2/FiO2 ratio as compared to value the day VAP is diagnosed * No appearance of new signs of sepsis All 3 criteria must be fulfilled 7 to 10 days after antibiotic initiation Recurrence is defined as: -a clinically suspected VAP (fever, radiological opacity, increase in ventilation need) A microbiological confirmation with Pa recovered at a significant level from lung sample (≥10^4/ml for BAL or ≥10^5/ml for tracheal aspirate or ≥ 10^3 CFU/mL for plugged telescopic catheter).
11 secondary outcomes
Resolution of ventilator-associated pneumonia symptoms
Time frame: Day 7 +/- 3 days
Incidence of new ventilator-associated pneumonia
Time frame: Day 7 +/- 3 days and day 14
Clinical improvement, defined by a modified Clinical pulmonary infection score <4 (range 0-12, with higher score indicating worse outcome) and no new Pseudomonas aeruginosa ventilator-associated pneumonia episode
Time frame: Day 14
Incidence of Pseudomonas aeruginosa detection in respiratory samples
Time frame: Day 3, Day 5, Day 7, Day 10, Day 14 and Day 28
Number of days alive
Time frame: Day 28
Number of day without invasive mechanical ventilation
Time frame: Day 28
Number of day without antibiotics
Time frame: Day 28
Anti-phage antibody presence and titers,
Time frame: Day 1, 7, 10, 14 and 28
Phage neutralization titers
Time frame: Day 1, 7, 10, 14 and 28
Mortality rate
Time frame: Day 28 and Day 60
Prevalence of ESBL-producing and carbapenem-resistant Gram-negative bacteria in fecal and tracheal aspirate samples
Time frame: Day 28
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 4 Sep 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.
16 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 Bacteriophages GMP in people with Ventilator Associated Bacterial Pneumonia and Pseudomonas Aeruginosa Infection, run by Assistance Publique - Hôpitaux de Paris at 16 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 8 inclusion and 9 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 Alexandre BLEIBTREU, MD (+ 33 1 84 02 76 92, alexandre.bleibtreu@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients alive and cured at D28 and without any recurrence of Pa-VAP between the initial episode and D28. (time frame: 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 4 Sep 2026.