Bacteriophage Therapy for Orthopedic Implant-Associated Infections
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
bacteriophage preparation
Biological/VaccineAfter 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Bacteriophage TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bacterial eradication rate after bacteriophage 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
Time frame
Within 7 days after initiation of therapySecondary outcomes
1
Clinical and inflammatory response improvement
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.
Time frame
Within 1 month after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: