Health TrialsbyHealthPanel

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

ConditionVAP - Ventilator Associated Pneumonia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phage cocktail administered via nebulization

    Drug

    Phage cocktail administered via nebulization，BID

  • Nebulized normal saline inhalation therapy

    Drug

    Nebulized normal saline inhalation therapy, BID

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: control groupPlacebo comparator 1 intervention
Group B: phage therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical response rate

Time frame
From enrollment to the end of treatment (within 10 days of enrollment)

Secondary outcomes

1

Bacterial clearance rate

Time frame
10 days after enrollment
2

28-day mortality

Time frame
28 days after enrollment
3

Length of hospital stay

Time frame
28 days after enrollment
4

Length of invasive mechanical ventilation

Time frame
28 days after enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese PLA General Hospital

Lead sponsor

Peking University Third Hospital

Collaborator

Zhengzhou Central Hospital

Collaborator

Henan Provincial People's Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Chinese the Eighth Medical Center of the General Hospital of the People's Liberation Army

Collaborator

The First Medical Center of Chinese PLA General Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: