Implant Infection, Orthopedic
Conditions
Keywords
Bacteriophage Therapy, Orthopedic Implant-Associated Infections
Brief summary
A Prospective, Single-Center, Single-Arm Clinical Study with a Pre-Post Self-Controlled Design Evaluating the Efficacy and Safety of Bacteriophage Therapy for Refractory Orthopedic Implant-Associated Infections
Interventions
BIOLOGICALbacteriophage preparation
After undergoing standard surgical debridement for orthopedic implant-associated infection. Bacteriophage preparation was administered primarily via postoperative indwelling catheter infusion. An appropriate volume of bacteriophage solution (adjusted according to joint cavity size and clinical assessment) was instilled directly through the catheter into the infected site, twice daily (bid) for 3 consecutive days per treatment cycle. During administration, strict aseptic procedures were maintained, and the distribution of the bacteriophage preparation within the joint cavity was ensured. Throughout the treatment period, patients were closely monitored for local and systemic adverse events related to bacteriophage therapy.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Known allergy or hypersensitivity to bacteriophages or any components of the bacteriophage preparation; * Pregnant or breastfeeding women; * Participation in another interventional clinical trial within the study period; * Lack of feasible routes of administration other than intravenous injection; * Patients deemed unsuitable for participation in this study by the investigator; * Inability or unwillingness of the subject to comply with study procedures.
Exclusion criteria
* Withdrawal of informed consent by the participant at any time during the study; * Occurrence of serious adverse events related to bacteriophage therapy that, in the investigator's judgment, necessitate discontinuation of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial eradication rate after bacteriophage therapy | Within 7 days after initiation of therapy | The primary outcome of this study is the eradication of the target pathogen following bacteriophage treatment. Microbiological samples from the infection site will be collected before treatment and on days 1, 3, 5, and 7 after initiation of bacteriophage therapy for bacterial culture and identification. Bacterial eradication is defined as two consecutive negative cultures for the target pathogen after completion of bacteriophage therapy. If the target bacteria are still detected on day 3 or day 5, a reassessment will be performed to determine whether an additional cycle of bacteriophage therapy is required |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and inflammatory response improvement | Within 1 month after treatment | The secondary outcome is the improvement of clinical symptoms and inflammatory indicators after bacteriophage therapy. Clinical improvement is defined by meeting the following criteria: 1. Body temperature returns to normal, and local signs of infection (swelling, erythema, pain) are significantly alleviated or resolved, with satisfactory wound healing (no purulent discharge or exudation); 2. Blood routine parameters (white blood cell count, neutrophil ratio) and inflammatory markers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), show a progressive decline and return to normal ranges; 3. Drainage from the infection site is significantly reduced or absent; 4. Imaging examinations (e.g., X-ray, CT, or MRI) demonstrate significant resolution of inflammatory lesions. |
Countries
China
Contacts
CONTACTZhao Ming Ye
CONTACTMin Jun Yao
Outcome results
None listed