drug-resistant bacterial infections
Conditions
Interventions
Sponsors
Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years (including the boundary values), no gender restriction; 2. Patients with drug-resistant bacterial infections (based on antibiotic susceptibility test results from this hospital or other tertiary hospitals); 3. The pathogenic bacteria infecting the patient should meet at least one of the following conditions: (1) 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 (2) The pathogen is sensitive to key antibiotics in vitro but the treatment with these antibiotics is ineffective or the effect is not obvious (patients with recurrent infection by target bacteria for 7 days or more during which antibiotic treatment fails to clear the infection); (3) The use of key sensitive antibiotics is limited for the pathogen (e.g., organ toxicity or allergy to the antibiotic); 4. At least one lytic bacteriophage can be screened; 5. Administration is possible via infection site spraying, external application, nebulized inhalation, perfusion, local injection, or drainage tubes; 6. The subject and family members (or guardians) have fully read, understood, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Bacterial infection that can be effectively controlled by antibiotic therapy. 2.Unresolved surgical conditions, such as undrained abscess or obstruction. 3.Presence of heart, liver, lung, kidney or other vital organ failure. 4.Patients with severe immunological disorders. 5.Conditions in which the planned phage administration route cannot effectively reach the drug-resistant bacteria. 6.No available phage(s) cover the patient’s infecting bacterial strain. 7.No feasible administration route other than intravenous injection. 8.Other conditions judged by the investigator to be inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Bacterial eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Symptom Resolution Rate; | — |
Countries
China
Contacts
Public ContactLi Jie
Drum Tower Hospital
Outcome results
None listed