VAP - Ventilator Associated PneumoniaNCT07202234
Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
A study testing Phage cocktail administered via nebulization and Nebulized normal saline inhalation therapy in people with VAP - Ventilator Associated Pneumonia, run by Chinese PLA General Hospital.
Trial summary
The purpose of this study is to systematically evaluate the efficacy and safety of bacteriophage cocktail therapy in patients with ventilator-associated pneumonia caused by Gram-negative bacterial infections. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- Phage cocktail administered via nebulization and Nebulized normal saline inhalation therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 May 2028
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ventilator-associated pneumonia (VAP);
- Identified infection with MDR Klebsiella pneumoniae, Acinetobacter baumannii, or Pseudomonas aeruginosa via MROSE evaluation and antimicrobial susceptibility testing (AST) from this or other tertiary hospitals;
- Aged 18 to 85 years;
- Written informed consent obtained from the patient or legal guardian.
Who cannot join
- Pregnant or breastfeeding women;
- FiO₂ ≥ 70% or PEEP ≥ 15 cmH₂O;
- Hemodynamic instability (vasopressor dose increased by ≥30% in the last 6 hours or norepinephrine > 0.5 μg/kg/min);
- Known allergy to phage components.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial of Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
The purpose of this study is to systematically evaluate the efficacy and safety of bacteriophage cocktail therapy in patients with ventilator-associated pneumonia caused by Gram-negative bacterial infections.
Read the detailed description
This study investigates the clinical application of bacteriophage therapy in severe infections through a prospective, randomized, multi-center trial targeting ventilator-associated pneumonia (VAP) caused by multidrug-resistant Gram-negative bacteria. The trial will comprehensively assess the efficacy, safety, and applicability of inhaled bacteriophage cocktail therapy, providing high-quality clinical evidence to support the establishment of an evidence-based framework for phage therapy. The primary endpoint is clinical response rate, with secondary endpoints including bacterial clearance and 28-day mortality, aiming to determine the therapeutic potential and clinical value of phage cocktails in VAP treatment.
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- Phage cocktail administered via nebulization, Nebulized normal saline inhalation therapy
- Keywords
- phage therapy, ventilator-associated pneumonia, phage cocktail
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phage cocktail administered via nebulizationDrug
Phage cocktail administered via nebulization，BID
Nebulized normal saline inhalation therapyDrug
Nebulized normal saline inhalation therapy, BID
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Nebulized normal saline inhalation therapy Receives: Drug: Nebulized normal saline inhalation therapy |
| phage therapy group | Experimental | Phage cocktail administered via nebulization Receives: Drug: Phage cocktail administered via nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
Measured: From enrollment to the end of treatment (within 10 days of enrollment)
Secondary outcomes (6)
Bacterial clearance rate
Measured: 10 days after enrollment
28-day mortality
Measured: 28 days after enrollment
Length of hospital stay
Measured: 28 days after enrollment
Length of invasive mechanical ventilation
Measured: 28 days after enrollment
CPIS score
Full Title: Clinical Pulmonary Infection Score (CPIS);Range: Minimum: 0, Maximum: 12
;Interpretation: Higher score indicates more severe infection.
Measured: 1，5，10 days after enrollment
SOFA score
Full Title: Sequential Organ Failure Assessment (SOFA) Score;Range: Minimum: 0, Maximum: 24
;Interpretation: Higher score indicates greater organ dysfunction.
Measured: 1，5，10 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Zhengzhou Central Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Chinese the Eighth Medical Center of the General Hospital of the People's Liberation Army, The First Medical Center of Chinese PLA General Hospital
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202234
- Sponsor's protocol ID
- Phage-2025YFC3408504
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT07202234
- Acronym / sponsor ID
- Phage-2025YFC3408504
- Conditions
- VAP - Ventilator Associated Pneumonia
- Keywords
- phage therapy, ventilator-associated pneumonia, phage cocktail
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Zhengzhou Central Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Chinese the Eighth Medical Center of the General Hospital of the People's Liberation Army, The First Medical Center of Chinese PLA General Hospital
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 1 Oct 2025 (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 purpose of this study is to systematically evaluate the efficacy and safety of bacteriophage cocktail therapy in patients with ventilator-associated pneumonia caused by Gram-negative bacterial infections.
Detailed description
This study investigates the clinical application of bacteriophage therapy in severe infections through a prospective, randomized, multi-center trial targeting ventilator-associated pneumonia (VAP) caused by multidrug-resistant Gram-negative bacteria. The trial will comprehensively assess the efficacy, safety, and applicability of inhaled bacteriophage cocktail therapy, providing high-quality clinical evidence to support the establishment of an evidence-based framework for phage therapy. The primary endpoint is clinical response rate, with secondary endpoints including bacterial clearance and 28-day mortality, aiming to determine the therapeutic potential and clinical value of phage cocktails in VAP treatment.
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 |
|---|---|---|
| control group | Placebo comparator | Drug: Nebulized normal saline inhalation therapyNebulized normal saline inhalation therapy |
| phage therapy group | Experimental | Drug: Phage cocktail administered via nebulizationPhage cocktail administered via nebulization |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with ventilator-associated pneumonia (VAP);
- Identified infection with MDR Klebsiella pneumoniae, Acinetobacter baumannii, or Pseudomonas aeruginosa via MROSE evaluation and antimicrobial susceptibility testing (AST) from this or other tertiary hospitals;
- Aged 18 to 85 years;
- Written informed consent obtained from the patient or legal guardian.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women;
- FiO₂ ≥ 70% or PEEP ≥ 15 cmH₂O;
- Hemodynamic instability (vasopressor dose increased by ≥30% in the last 6 hours or norepinephrine > 0.5 μg/kg/min);
- Known allergy to phage components.
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 |
|---|---|---|
| Phage cocktail administered via nebulizationPhage cocktail administered via nebulization，BID | Drug | phage therapy group |
| Nebulized normal saline inhalation therapyNebulized normal saline inhalation therapy, BID | Drug | control group |
Primary outcome
Clinical response rate
Time frame: From enrollment to the end of treatment (within 10 days of enrollment)
6 secondary outcomes
Bacterial clearance rate
Time frame: 10 days after enrollment
28-day mortality
Time frame: 28 days after enrollment
Length of hospital stay
Time frame: 28 days after enrollment
Length of invasive mechanical ventilation
Time frame: 28 days after enrollment
CPIS score
Time frame: 1，5，10 days after enrollment
SOFA score
Time frame: 1，5，10 days after enrollment
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 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Phage cocktail administered via nebulization and Nebulized normal saline inhalation therapy in people with VAP - Ventilator Associated Pneumonia, run by Chinese PLA General Hospital.
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 4 inclusion and 4 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Xiuli Wang (+86 18686045253, wxl981003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate (time frame: From enrollment to the end of treatment (within 10 days of enrollment)). 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 1 Oct 2025.