drug-resistant bacterial infections
Conditions
Interventions
intervention group:phage therapy
Sponsors
Yixing People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years; 2. Patients with drug-resistant bacterial infections (based on drug susceptibility test results from this hospital or other tertiary hospitals); 3. The pathogens infecting the patients should meet at least one of the following conditions: a) The pathogen is resistant to key antibiotics: 1) Acinetobacter baumannii: resistant to carbapenems; 2) Enterobacteriaceae (such as Klebsiella pneumoniae, Escherichia coli): resistant to carbapenems or cephalosporins; 3) Pseudomonas aeruginosa: resistant to carbapenems; 4) Enterococcus: resistant to vancomycin; 5) Staphylococcus aureus: resistant to methicillin or vancomycin; 6) Stenotrophomonas maltophilia. *Reference: WHO Bacterial Priority Pathogens List, 2024 b) The pathogen is sensitive in vitro to key antibiotics, but treatment with these antibiotics is ineffective or has no obvious effect (patients with target bacteria repeatedly infected for 7 days or more, during which antibiotic treatment failed to eradicate the infection); c) Use of key sensitive antibiotics is limited due to factors such as organ toxicity or allergy to the antibiotic; 4. At least one lytic bacteriophage can be screened; 5. The drug can be administered via infection site spraying, topical application, nebulized inhalation, perfusion, local injection, or drainage tubes; 6. The subject and their family (or guardian) have fully read, understood, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Bacterial infection controllable with 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 |
|---|---|
| Safety Outcomes;Bacterial eradication rate;Clinical response rate; | — |
Countries
China
Contacts
Public ContactJunjie Lu
Yixing People's Hospital
Outcome results
None listed