Pseudomonas aeruginosa
Conditions
Interventions
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 28 days; 2. Confirmed diagnosis of cystic fibrosis (CF) based on the Chinese Expert Consensus on the Diagnosis and Treatment of Cystic Fibrosis (2023) or primary ciliary dyskinesia (PCD) based on the Chinese Expert Consensus on the Diagnosis and Treatment of Primary Ciliary Dyskinesia (2020); 3. Detection of Pseudomonas aeruginosa in lower respiratory tract secretions or bronchoalveolar lavage fluid (BALF), as defined by the Chinese Expert Consensus on the Diagnosis and Treatment of Pseudomonas aeruginosa Lower Respiratory Tract Infections (2022); 4. No contraindications for nebulized inhalation or bronchoscopy; 5. Availability of at least one lytic bacteriophage active against the isolated Pseudomonas aeruginosa strain; 6. Written informed consent obtained from the participant (or legally authorized guardian for minors/incapacitated individuals) after full explanation of the study.
Exclusion criteria
Exclusion criteria: 1. Severely abnormal vital signs at screening; 2. Any primary or secondary immunodeficiency state (including drug-induced), if the degree of immunosuppression exceeds the typical levels associated with cystic fibrosis (CF)/primary ciliary dyskinesia (PCD) or their standard treatments; 3. Severe neutropenia, defined as an absolute neutrophil count (ANC) < 500/µL; 4. Prior bacteriophage therapy within 3 months before screening; 5. Participation in another interventional clinical trial within 3 months before screening; 6. Investigator-determined unsuitability for study participation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptom relief rate;Acute systemic antibiotic usage rate;Phage activity level; | — |
Primary
| Measure | Time frame |
|---|---|
| Change in the Pseudomonas aeruginosa load;Change in Pulmonary Function Indices (ppFEV1, FEV1, etc.) from Baseline; | — |
Countries
China
Contacts
Public ContactLiling Qian
Shanghai Children's Hospital
Outcome results
None listed