NCT07533292

Bacteriophage Therapy for Orthopedic Implant-Associated Infections

Prospective, Single-Center, Single-Arm, Pre-Post Self-Controlled Study Evaluating the Efficacy and Safety of Bacteriophage Therapy in Orthopedic Implant-Associated Infections

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Orthopedic
• Implant Infection

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2026-04-05
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: China