Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phage cocktail administered via nebulization, Nebulized normal saline inhalation therapy.
- Who it may be relevant to
- Registry conditions: VAP - Ventilator Associated Pneumonia. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial of Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
Overview
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.
Interventions
- Drug Phage cocktail administered via nebulization
Phage cocktail administered via nebulization，BID - Drug Nebulized normal saline inhalation therapy
Nebulized normal saline inhalation therapy, BID
Primary outcome measures
- Clinical response rate [Time frame: From enrollment to the end of treatment (within 10 days of enrollment)]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07202234 · Phage-2025YFC3408504