Drug-resistant skin infections
Conditions
Interventions
Control group:Physically indistinguishable 0.9% saline solution (7-day course)
Phage Intervention Group:Phage Cocktail Therapy (7-day course)
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, any gender; 2. Clinically confirmed skin infection with wound area of 4-225 cm^2; 3. Infection not involving deep tissues, suitable for topical medication, and not expected to require surgical intervention; 4. Pathogenic bacteria detected in secretions or wound samples; 5. Pathogen resistant to key antibiotics (e.g., carbapenems) or showing poor response to antibiotic therapy despite in vitro susceptibility; 6. Patients who received systemic antimicrobial therapy within 72 h prior to enrollment with inadequate response may be included; 7. Subjects with reproductive potential must agree to use effective contraception during the study; 8. Voluntary signed informed consent and willingness/ability to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Infection controllable by existing antimicrobial agents, or pathogen insensitive to the phage cocktail used in this study; 2. Pregnant or lactating women; 3. Those whose infection symptoms improved after antimicrobial use within 72 hours prior to enrollment; 4. Current long-term or high-dose corticosteroids, immunosuppressants, chemotherapy, or other treatments that may interfere with study results; 5. Participation in other antimicrobial-related clinical trials within the past month; 6. Conditions including severe wound infections (e.g., necrotizing fasciitis), chronic inflammatory skin diseases, multiple limb ulcers, non-removable implants, or gangrene; 7. Those expected to require amputation surgery; 8. History of significant allergic diseases, immunodeficiency (including HIV-positive), mental disorders, or epilepsy; 9. Any other circumstances deemed by the investigator to be unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial Clearance Rate;Clinical Improvement Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;28-Day Post-Treatment Recurrence Rate; | — |
Countries
China
Contacts
Public ContactYang Yuan
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed