Wound infection
Conditions
Interventions
Control Group:Standard of Care (SC)
Experimental Group:Standard treatment (SC) combined with local phage therapy
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 88 Years
Inclusion criteria
Inclusion criteria: 1.Those with severe allergies to the excipients of the phage preparation; 2.Those with severe and uncontrollable systemic diseases (such as multiple organ failure with SOFA score > 12), and are expected to be unable to survive the transition period; 3.At least one lytic bacteriophage targeting the pathogen of the patient can be screened out from the bacteriophage library of this research unit (* This criterion is used to determine whether the patient is eligible to enter the experimental group). 4.The infected site of the patient is suitable and can tolerate local administration operations (such as spraying, external application, perfusion, flushing, etc.). 5.The expected survival period is over 14 days, and the patient can cooperate to complete the treatment and follow-up; 6.The subject himself/herself or his/her legal representative fully understood the research content and voluntarily signed the informed consent form; 7. Aged 18–88, no gender restrictions;
Exclusion criteria
Exclusion criteria: 1.Those who are severely allergic to phage preparations and excipients; 2.Those who have severe and uncontrollable systemic diseases (such as multiple organ failure with a SOFA score >12) and are expected to be unable to pass the transition period; 3.Pregnant or lactating women; 4.Those who are participating in other interventional clinical trials;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Pathogen Clearance Rate at Day 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessment (AEs, Laboratory Tests, Local Tolerability);Clinical Improvement Rate;Length of Hospital Stay (LOS);30-day All-Cause Mortality; | — |
Countries
China
Contacts
Public ContactLi Yang
Army Medical Center of PLA
Outcome results
None listed