Self-funded
Conditions
Interventions
Intervention Group:Phage Pleural Perfusion Therapy
Sponsors
The 8th Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 75 years old, gender not restricted. (2) Meeting the diagnostic criteria for empyema: a. Clinical manifestations include high fever, chest pain, dyspnea, etc.; b. Chest imaging (chest X-ray, CT) shows fluid in the pleural cavity, and the fluid obtained through ultrasound or CT-guided pleural puncture is confirmed to be pus (appearing purulent and turbid, with white blood cell count > 10×10?/L and polymorphonuclear leukocyte ratio > 80%). (3) Positive bacterial culture of pleural effusion (the pathogenic bacteria must be identified and be sensitive to at least one of the phages in the experimental phage cocktail). (4) After at least 3 days of standard treatment (closed thoracic drainage + intravenous infusion of sensitive antibiotics), the bacterial culture remains positive / the amount of fluid does not significantly decrease. (5) Voluntarily sign the informed consent form and be able to cooperate with the follow-up of the trial.
Exclusion criteria
Exclusion criteria: (1) Those known to be allergic to phage components. (2) Those with active pulmonary tuberculosis, fungal empyema or other non-bacterial thoracic infectious diseases. (3) Those with severe underlying diseases such as malignant tumors, severe autoimmune diseases, mental disorders, etc., and whose conditions have not been effectively controlled. (4) Those who have participated in other clinical trials within the past 3 months. (5) Pregnant women, lactating women or female patients planning to become pregnant during the trial period. (6) Those with severe pleural adhesions or pleural thickening, making effective thoracic drainage and local perfusion treatment impossible. (7) Those with an expected survival period of less than 3 months. (8) Those whom the researcher deems unsuitable for participation in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Adverse Reactions (ARs) / Serious Adverse Reactions (SARs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Absorption rate of pleural effusion;Bacterial culture negative conversion rate;Clinical symptom improvement rate;Overall therapeutic efficacy rate;The area under the curve of the concentration-time profile of active bacteriophages;Peak concentration of active bacteriophages;Peak time of active bacteriophages;Half-life of active bacteriophage elimination; | — |
Countries
China
Contacts
Public ContactWeihuang Zhang
The 8th Medical Center of Chinese PLA General Hospital
Outcome results
None listed