VAP - Ventilator Associated Pneumonia
Conditions
Keywords
phage therapy, ventilator-associated pneumonia, phage cocktail
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.
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
DRUGPhage cocktail administered via nebulization
Phage cocktail administered via nebulization，BID
DRUGNebulized normal saline inhalation therapy
Nebulized normal saline inhalation therapy, BID
Sponsors
Peking University Third Hospital
Zhengzhou Central Hospital
Henan Provincial People's Hospital
The First Affiliated Hospital of Zhengzhou University
The 8th medical center of chinese PLA general hospital
The First Medical Center of Chinese PLA General Hospital
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with ventilator-associated pneumonia (VAP); 2. 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; 3. Aged 18 to 85 years; 4. Written informed consent obtained from the patient or legal guardian.
Exclusion criteria
1. Pregnant or breastfeeding women; 2. FiO₂ ≥ 70% or PEEP ≥ 15 cmH₂O; 3. Hemodynamic instability (vasopressor dose increased by ≥30% in the last 6 hours or norepinephrine \> 0.5 μg/kg/min); 4. Known allergy to phage components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate | From enrollment to the end of treatment (within 10 days of enrollment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | 28 days after enrollment | — |
| Length of hospital stay | 28 days after enrollment | — |
| Bacterial clearance rate | 10 days after enrollment | — |
| CPIS score | 1，5，10 days after enrollment | Full Title: Clinical Pulmonary Infection Score (CPIS);Range: Minimum: 0, Maximum: 12 ;Interpretation: Higher score indicates more severe infection. |
| SOFA score | 1，5，10 days after enrollment | Full Title: Sequential Organ Failure Assessment (SOFA) Score;Range: Minimum: 0, Maximum: 24 ;Interpretation: Higher score indicates greater organ dysfunction. |
| Length of invasive mechanical ventilation | 28 days after enrollment | — |
Contacts
Primary ContactXiuli Wang
Backup ContactWeihua Zhang
Outcome results
None listed