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NCT Number: NCT07533292

Bacteriophage Therapy for Orthopedic Implant-Associated Infections

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

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Key information

Conditions

Orthopedic Implant Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Bacterial eradication rate after bacteriophage therapy

    Time frame: 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

Secondary outcomes

  1. Clinical and inflammatory response improvement

    Time frame: Within 1 month after treatment

    The secondary outcome is the improvement of clinical symptoms and inflammatory indicators after bacteriophage therapy. Clinical improvement is defined by meeting the following criteria:

    • 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);
    • 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;
    • Drainage from the infection site is significantly reduced or absent;
    • Imaging examinations (e.g., X-ray, CT, or MRI) demonstrate significant resolution of inflammatory lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Jun Yao

CONTACT

[email protected]

Zhao Ming Ye

CONTACT

[email protected]

86-1360651549

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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