Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
A Randomized Controlled Trial of Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
1 other identifier
interventional
248
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
October 1, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
October 1, 2025
September 1, 2025
2.6 years
August 26, 2025
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response rate
From enrollment to the end of treatment (within 10 days of enrollment)
Secondary Outcomes (6)
Bacterial clearance rate
10 days after enrollment
28-day mortality
28 days after enrollment
Length of hospital stay
28 days after enrollment
Length of invasive mechanical ventilation
28 days after enrollment
CPIS score
1，5，10 days after enrollment
- +1 more secondary outcomes
Study Arms (2)
control group
PLACEBO COMPARATORNebulized normal saline inhalation therapy
phage therapy group
EXPERIMENTALPhage cocktail administered via nebulization
Interventions
Phage cocktail administered via nebulization，BID
Nebulized normal saline inhalation therapy, BID
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Peking University Third Hospitalcollaborator
- Zhengzhou Central Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- The 8th medical center of chinese PLA general hospitalcollaborator
- The First Medical Center of Chinese PLA General Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 26, 2025
First Posted
October 1, 2025
Study Start
November 1, 2025
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share