Bronchiectasis combined with Pseudomonas aeruginosa infection
Conditions
Interventions
Trial Group:Phage therapy
Sponsors
The affiliated hospital of Guizhou Medical Univeisity
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The subject is a bronchiectasis patient with a chronic pulmonary Pseudomonas aeruginosa infection. 2.The pathogenic bacterium in the patient's lung infection includes Pseudomonas aeruginosa, but co-infection with other types of bacteria is not excluded. 3.At least one lytic phage can be screened and matched for the isolated bacterial strain. 4.The phage preparation can be administered via nebulized inhalation. 5.The subject and their family members (or legal guardian) have fully read,understood, and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Administration via aerosol inhalation is not permitted. 2.Patients with severe, unstable clinical conditions (e.g., sepsis, progressive cancer, acute rejection) that preclude study completion, or conditions where clinical symptoms cannot be explained or managed. 3.Pregnant or lactating women. 4. Patients with severe active fungal or viral infections, severe immunodeficiency diseases (e.g., advanced AIDS), or other severe systemic underlying conditions deemed by the investigator as unsuitable for participation. 5. Concurrent participation in any clinical trials involving investigational drugs or other bacteriophage therapies at the time of enrollment in this study. 6.At screening, hematology results showing: hemoglobin 5 × upper limit of normal (ULN), or AST >5 × ULN, or total bilirubin >3 × ULN; (2) Total bilirubin >1.5 × ULN accompanied by ALT >3 × ULN or AST >3 × ULN. 7.Patients considered unsuitable for participation by the investigator’s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Pseudomonas aeruginosa load; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in clinical symptoms (e.g., temperature, complete blood count, cough and sputum production); | — |
Countries
China
Contacts
Public ContactHu Xiwei
The affiliated hospital of Guizhou Medical Univeisity
Outcome results
None listed