Bacteriophage Therapy for Orthopedic Implant-Associated Infections

NCT07533292 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-0401
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Orthopedic; Implant Infection

Keywords

Bacteriophage Therapy; Orthopedic Implant-Associated Infections

Outcome Measures

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

  Within 7 days after initiation of therapy

Secondary Outcomes (1)

• Clinical and inflammatory response improvement

  Within 1 month after treatment

Study Arms (1)

Bacteriophage Therapy

EXPERIMENTAL

To evaluate the infection control effect of bacteriophage therapy in treatment of refractory orthopedic implant-associated infections

Biological: bacteriophage preparation

Interventions

bacteriophage preparation BIOLOGICAL

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.

Bacteriophage Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China 310000, China

Location

Central Study Contacts

Zhao Ming Ye

CONTACT

86-1360651549; yezhaominghz@163.com

Min Jun Yao

CONTACT

yao_minjun@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CN (1)