Bacteriophage Therapy for Orthopedic Implant-Associated Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bacteriophage preparation.
- Who it may be relevant to
- Registry conditions: Orthopedic, Implant Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Single-Center, Single-Arm, Pre-Post Self-Controlled Study Evaluating the Efficacy and Safety of Bacteriophage Therapy in Orthopedic Implant-Associated Infections
Overview
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
- Biological bacteriophage 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 maintaine
Primary outcome measures
- Bacterial eradication rate after bacteriophage therapy [Time frame: Within 7 days after initiation of therapy]
Secondary outcome measures (1)
- Clinical and inflammatory response improvement [Time frame: Within 1 month after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07533292 · 2025-0401