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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
Phage cocktail administered via nebulization,BID
Nebulized normal saline inhalation therapy, BID
Clinical response rate
Time frame: From enrollment to the end of treatment (within 10 days of enrollment)
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
Full Title: Clinical Pulmonary Infection Score (CPIS);Range: Minimum: 0, Maximum: 12 ;Interpretation: Higher score indicates more severe infection.
Time frame: 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.
Time frame: 1,5,10 days after enrollment
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