Pseudomonas aeruginosa
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old; 2. Bronchiectasis were diagnosed according to the 2020 Chinese Expert Consensus criteria for bronchiectasis; COPD Diagnosis according to 2023 GOLD Global Initiative criteria for Chronic Obstructive Pulmonary Disease; 3. Lower respiratory tract secretions or bronchoalveolar lavage fluid culture pathogen Pseudomonas aeruginosa (Positive judgment according to the expert Consensus 2022 standard for Diagnosis and Treatment of lower respiratory tract infections of Pseudomonas aeruginosa in China: Bronchial aspiration (>=10^5CFU/mL), bronchoalveolar lavage (>=10^4CFU/mL), protective brush specimen (>=10^3CFU/mL); In patients with lower respiratory tract infection, PA positive in pleural fluid culture and blood culture can be considered positive after exclusion of contamination. Clinical suspicion of PA infection is high, routine examination is negative, especially the empirical antibacterial treatment is not effective, positive diagnosis can be made with the help of molecular diagnosis results such as second-generation sequencing, gene chip, PCR, etc. Patients with repeated positive culture of PA should be tested for drug sensitivity at least once every 3 days); 4. The pathogenic bacteria infected by the patient should meet one of the following conditions and the bactericidal test of in vitro is positive: (1) The pathogenic bacteria meet the diagnostic criteria of DTR-PA (see above); (2) The pathogen is sensitive to the key antibiotic in vitro, but the antibiotic treatment is ineffective for 7 days (failing to achieve the goal of eliminating the pathogen/improving clinical symptoms); (3) The use of critical sensitive antimicrobials by pathogens is limited (such as organ toxicity or patients with allergic reactions to antimicrobials); 5. Can be administered by aerosol inhalation or bronchoscopic perfusion; 6. The subjects and their family members (or guardians) should fully read, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe abnormal vital sians during screening; 2. Bacterial infection can be effectively controlled by antimicrobial therapy; 3. Those who cannot tolerate aerosol inhalation or bronchoscopy infusion; 4. Subjectand their family members (or guardian) refuse to participate; 5. Patients unsuitable by the investigator toparticipate in the study, such as pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptoms improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial clearance or reduction;Temperature;Blood routine;C-reactive protein;Procalcitonin;Inflammatory cytokine spectrum;Pulmonary function;Blood gas analysis;Chest imaging results; | — |
Countries
China
Contacts
Shenzhen University General Hospital