Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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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

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VAP - Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control group

Nebulized normal saline inhalation therapy

Group Type PLACEBO_COMPARATOR

Nebulized normal saline inhalation therapy

Intervention Type DRUG

Nebulized normal saline inhalation therapy, BID

phage therapy group

Phage cocktail administered via nebulization

Group Type EXPERIMENTAL

Phage cocktail administered via nebulization

Intervention Type DRUG

Phage cocktail administered via nebulization，BID

Interventions

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Phage cocktail administered via nebulization

Phage cocktail administered via nebulization，BID

Intervention Type DRUG

Nebulized normal saline inhalation therapy

Nebulized normal saline inhalation therapy, BID

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No