Bronchiectasis combined with Pseudomonas aeruginosa chronic infection
Conditions
Interventions
Bacteriophage therapy group:Bacteriophage cocktail Pae-PC1 10ml , aerosol inhalation , 2/day
Sponsors
College of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–85 years; 2.Meets diagnostic criteria for bronchiectasis (per the 2021 Chinese Expert Consensus on Diagnosis and Management of Bronchiectasis in Adults); 3.Fulfills criteria for chronic Pseudomonas aeruginosa (PA) infection, with >=2 episodes of bronchiectasis exacerbation requiring oral/intravenous anti-PA antibiotics within 12 months prior to enrollment; 4.PA isolated from respiratory samples (spontaneous/induced sputum or lower respiratory specimens obtained via bronchoscopy) within 1 week before enrollment; 5.Failure to eradicate PA with prior antibiotic therapy;6Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Uncontrolled severe bronchial asthma; 3.Cognitive or psychiatric impairment affecting the ability to provide informed consent; 4.Negative PA sputum culture after anti-PA antibiotic therapy within the past 3 months; 5.History of severe airway spasm or intolerance to nebulized therapy; 6.Unstable cardiovascular or cerebrovascular diseases, defined as clinical deterioration (e.g., unstable angina, rapid atrial fibrillation, cerebral hemorrhage, acute cerebral infarction) within 30 days prior to screening; 7.Progressive or uncontrolled systemic diseases, including advanced malignancies, or severe respiratory, circulatory, neurological, or psychiatric disorders, as assessed by the investigator to be unstable or likely to worsen during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The negative rate of PA in 12-week sputum culture;Blood biochemistry;Bacteriophage neutralizing antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine examination;C-Reactive Protein, CRP;Quality of Life;Interleukin-6, IL-6;Pulmonary Function;Procalcitonin, PCT;Incidence of adverse events;Chest computed tomography; | — |
Countries
China
Contacts
Public ContactLixin Xie
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed