Drug-resistant bacterial respiratory infections
Conditions
Interventions
Experimental Group:Bacteriophage cocktail
Sponsors
Wuhan Jinyintan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years; 2. Clinically and laboratory-confirmed bacterial lower respiratory tract infection (such as community-acquired pneumonia, hospital-acquired pneumonia/ventilator-associated pneumonia, bronchiectasis, or acute exacerbation of COPD with bacterial infection), with successful isolation of drug-resistant bacterial strains; 3. Bacterial quantitative culture results or clinical evidence suggesting failure of conventional antibiotic treatment (e.g., suboptimal efficacy after treatment with sensitive antibiotics, recurrent infections >=2 times within the past 3 months, or inability to discontinue antibiotics after continuous use for >=2 months), or limitations/contraindications to the use of key antibiotics due to hepatic or renal dysfunction, allergies, intolerance, etc.; 4. At least one bacteriophage capable of lysing the drug-resistant bacteria can be identified; 5. In the acute phase of respiratory infection or acute exacerbation of chronic respiratory infection, and aerosol inhalation administration is feasible, and the subject's clinical condition allows for local administration via the respiratory tract; 6. The subject or their legal representative voluntarily signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with extremely unstable vital signs and a very high risk of death within 48 hours, or those in septic shock who remain unstable despite adequate fluid resuscitation and hemodynamic support, including those with significantly decreased PaO2/FiO2 ratio and significantly increased SOFA score, indicating a critical condition; 2. Phage therapy is not recommended if any of the following conditions are present, unless clinically assessed that the patient has no other feasible antimicrobial treatment options besides phage therapy: unstable vital signs (temperature, heart rate, blood pressure, respiration); progressive malignancy; severe immune system disorders; concomitant renal insufficiency (eGFR < 30 ml/min/1.73m2), or patients undergoing CRRT, hemodialysis, or peritoneal dialysis; 3. Concomitant severe liver disease: decompensated cirrhosis, liver failure, Child-Pugh class C; 4. Concomitant hematological diseases: severe anemia (HGB < 60g/L), thrombocytopenia (<50 × 10^9/L), agranulocytosis, leukemia, hemophagocytic syndrome, coagulation disorders; 5. Patients with concomitant severe heart failure (NYHA class III-IV); 6. Patients with concomitant sepsis, peritonitis, pleuritis, and other systemic infections; 7. Patients with concomitant HIV infection, organ transplantation, or long-term use of corticosteroids or immunosuppressants; 8. History of severe allergic reaction to phage preparations or their excipients; 9. Inability to receive nebulized inhalation administration or where nebulized inhalation administration may worsen the condition (e.g., severe bronchospasm, significant ventilation/perfusion mismatch); 10. Pregnant or breastfeeding women; 11. Patients participating in other interventional clinical trials that may interfere with the assessment of the primary endpoint of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriological outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of clinical symptoms;Improvement of infection indicators;Improvement of imaging indicators; | — |
Countries
China
Contacts
Public ContactChaolin Huang
Wuhan Jinyintan Hospital
Outcome results
None listed