Patients with respiratory tract infections caused by multi-drug resistant Pseudomonas aeruginosa
Conditions
Interventions
Control group:Antibiotics combined with normal saline
Experimental group:Antibiotics combined with fixed formula bacteriophages
Sponsors
The Army Characteristic Medical Center of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 88 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-88 years old with multidrug-resistant Pseudomonas aeruginosa respiratory infections; 2. The pathogenic bacteria are resistant to multiple key antibiotics recommended by the guidelines or are sensitive but have poor therapeutic effects; 3. The isolates from the patients are highly sensitive to the fixed phage cocktail formula; 4. They can accept and tolerate inhalation administration; 5. The subjects and their family members (or guardians) have fully read, understood, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Patients who are intolerant to nebulization inhalation or have contraindications for nebulization inhalation such as severe airway hyperresponsiveness and active massive hemoptysis; 3.Those who are known to be allergic to any excipient component in phage preparations; 4.Suffering from progressive or uncontrollable irreversible systemic diseases, such as advanced malignant tumors, severe respiratory, circulatory, neurological or mental system diseases; 5.Researchers believe that patients may die within 48 hours and fail to complete the primary endpoint assessment; 6.Patients who were determined by the researchers to be unsuitable for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clearance rate of the target pathogenic bacteria (MDR-PA) in the lower respiratory tract samples on the 8th day of the treatment was studied; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security Index;Length of ICU stay;28 days without ventilator use;28-day all-cause mortality;Clinical Symptom Improvement Rate;14-day target bacterial clearance rate; | — |
Countries
China
Contacts
Public ContactZhen Wang;Qiu Zhong
The Army Characteristic Medical Center of the People's Liberation Army of China
Outcome results
None listed