drug-resistant bacterial infections
Conditions
Interventions
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–65 years old; 2.Patients with drug-resistant bacterial infections (diagnosed based on antimicrobial susceptibility test results from this hospital or other tertiary hospitals). 3.The pathogenic bacteria causing infection meet at least one of the following criteria: 1) Resistant to key antibiotics: Acinetobacter baumannii: carbapenem-resistant; Enterobacterales (e.g., Klebsiella pneumoniae, Escherichia coli): carbapenem-resistant or cephalosporin-resistant; Pseudomonas aeruginosa: carbapenem-resistant; Enterococci: vancomycin-resistant; Staphylococcus aureus: methicillin-resistant or vancomycin-resistant; Stenotrophomonas maltophilia; Reference: WHO Bacterial Priority Pathogens List, 2024 ;2) Pathogens susceptible to key antibiotics in vitro, but antibiotic treatment is ineffective or shows poor clinical response (persistent or recurrent target bacterial infection for =7 days despite antibiotic therapy). 3) Contraindications to the use of appropriate susceptible antibiotics (e.g., organ toxicity, history of hypersensitivity to the antibiotic). 4.At least one lytic bacteriophage is available against the isolated pathogen. 5.Administration is feasible via local application, spraying, wet dressing, aerosol inhalation, perfusion, local injection, drainage tube, or other local routes. 6.The subject and family members (or legal guardian) have fully read, understood, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Bacterial infection can be effectively controlled by conventional antibiotic therapy. 2.Presence of heart, liver, lung, or other vital organ failure. 3.Severe immunological disorders. 4.Conditions in which the planned phage administration route cannot effectively reach the site of drug-resistant bacterial infection. 5.No available phage(s) match the patient’s infecting pathogen. 6.No feasible administration route other than intravenous injection. 7.Other conditions judged by the investigator to be inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial eradication rate; | — |
Countries
China
Contacts
Public ContactJin Ke
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed