Bacteriophage Therapy for Orthopedic Implant-Associated Infections

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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.

Study 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

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China