Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Chinese PLA General Hospital

Collaborating Sponsors:

Peking University Third Hospital

Zhengzhou Central Hospital

Conditions:

VAP - Ventilator Associated Pneumonia

Eligibility:

All Genders

18-85 years

Phase:

NA

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 inf...

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) cau...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 31 2028

Estimated Enrollment :

248 Patients enrolled

Trial Details

Trial ID

NCT07202234

Start Date

November 1 2025

End Date

May 31 2028

Last Update

October 1 2025

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