Acute respiratory tract infection, acute urinary tract infection, infection after kidney transplantation, infection after liver transplantation, respiratory tract infection after lung transplantation, and abdominal infection
Conditions
Interventions
Experimental group (Part 1):phage therapy
Control group (Part 1):None
Experimental group (Part 2):Phage environment disinfection and sterilization
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Part 1: 1.Diagnosed patients aged 18-70 with acute respiratory tract infection, acute urinary tract infection, infection after kidney transplantation, infection after liver transplantation, respiratory tract infection after lung transplantation, and abdominal infection. 2.Pathogenic bacteria meet one of the following conditions: (a) Pathogen drug sensitivity shows pan resistance or resistance to key antibiotics (refer to the latest "2024 List of Key Bacterial Pathogens" released by WHO in 2024): Acinetobacter baumannii, carbapenem resistant; Enterobacteriaceae bacteria, resistant to third-generation cephalosporins; Enterobacteriaceae bacteria, resistant to carbapenems; Pseudomonas aeruginosa, resistant to carbapenems; Staphylococcus aureus is methicillin-resistant. (b) Pathogenic bacteria are sensitive to key antibiotics outside the body, but the treatment with this antibiotic is ineffective or ineffective (ineffective is defined as repeated infection of the target bacteria in the patient for one week or more, during which continuous use of antibiotics cannot clear the infection); (c) Pathogenic bacteria have limited use of key sensitive antibiotics (in patients with organ dysfunction or allergies to these antibiotics); 3.There are already one or more bacteriophages in the phage library that can lyse drug-resistant bacteria; 4.It can be administered through external application, infection site spraying, nebulization inhalation, infusion, or catheter administration. Part 2: 1. Infectious diseases clinically diagnosed as needing dressing change, such as wound infection, burn infection, etc. 2. The infection is limited to local infection and there are no symptoms of systemic infection. 3. Patients need to sign an informed consent form, be fully informed, voluntarily participate in the study, and receive relevant treatment and follow-up.
Exclusion criteria
Exclusion criteria: Part 1: 1.Bacterial infections can be effectively controlled by antibiotic treatment; 2.There are no other routes of administration besides intravenous injection; 3.Patients deemed unsuitable for participation in this study by the researchers; Part 2: Apart from clinical diagnosis of infectious diseases, there are other serious underlying diseases or immune deficiencies (except for organ transplant patients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial eradication rate;Detection rate of all target bacterial strains in wound secretion bacterial culture; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement rate;Detection rate of all target bacterial strains in environmental cultivation;Recurrence rate within one month after treatment; | — |
Countries
China
Contacts
Public ContactLiu Bing
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed