OrthopedicPhase 3NCT07533292
Bacteriophage Therapy for Orthopedic Implant-Associated Infections
A Phase 3 study testing bacteriophage preparation in people with Orthopedic and Implant Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic, Implant Infection
- What is being tested?
- bacteriophage preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Min Jun Yao contact
China1 site
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China 310000
About this study
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
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
- Being tested
- bacteriophage preparation
- Keywords
- Bacteriophage Therapy, Orthopedic Implant-Associated Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacteriophage preparationBiological
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 group | Role | What they receive |
|---|---|---|
| Bacteriophage Therapy | Experimental | To evaluate the infection control effect of bacteriophage therapy in treatment of refractory orthopedic implant-associated infections Receives: Biological: bacteriophage preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 7 days after initiation of therapy
Secondary outcomes (1)
Clinical and inflammatory response improvement
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.
Measured: Within 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start5 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533292
- Sponsor's protocol ID
- 2025-0401
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to policy constraints, it was not clear whether information could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07533292
- Acronym / sponsor ID
- 2025-0401
- Conditions
- Orthopedic, Implant Infection
- Keywords
- Bacteriophage Therapy, Orthopedic Implant-Associated Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bacteriophage Therapy | Experimental | Biological: bacteriophage preparationTo evaluate the infection control effect of bacteriophage therapy in treatment of refractory orthopedic implant-associated infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bacteriophage preparationAfter 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. | Biological | Bacteriophage Therapy |
Primary outcome
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
1 secondary outcome
Clinical and inflammatory response improvement
Time frame: Within 1 month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided. Due to policy constraints, it was not clear whether information could be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Jun Yao contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bacteriophage preparation in people with Orthopedic and Implant Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Ming Ye (86-1360651549, yezhaominghz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial eradication rate after bacteriophage therapy (time frame: Within 7 days after initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.