Periprosthetic Joint InfectionPhase 1/2NCT06942624
Phage Therapy for the Treatment of a Chronic Enterococcus Faecium Periprosthetic Joint Infection
A Phase 1/2 study testing Phage Therapy in people with Periprosthetic Joint Infection, run by Orthopaedic Innovation Centre at 1 site in Canada.
Trial summary
This purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of a bacteriophage therapy in a patient with a methicillin-susceptible Enterococcus faecium (E. faecium) prosthetic joint infection (PJI) of the hip. We have exhausted all surgical and medical management of PJI for our patient. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Periprosthetic Joint Infection
- What is being tested?
- Phage Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- May 2025to Jun 2026
- Phase
- Phase 1/2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This N-of-1 Phage therapy is designed for one patient who meet the following conditions
- Willingness to provide signed and dated informed consent form to participate in the clinical study
- Chronic prosthetic joint infection
- History of multiple surgical and medication managements with no success
Who cannot join
- below 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Concordia Hospital
Winnipeg, Manitoba, R2K 3S8
Sarah Tran, 204-926-1231, stran@orthoinno.com
Trevor Gascoyne, 204-926-1235, tgascoyne@orthoinno.com
About this study
This purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of a bacteriophage therapy in a patient with a methicillin-susceptible Enterococcus faecium (E. faecium) prosthetic joint infection (PJI) of the hip. We have exhausted all surgical and medical management of PJI for our patient.
The phage will be administered to the study patient during a 14 days period via intravenous and intra-articular. The patient will be monitored in clinic for up to 1 year.
Read the detailed description
This is a single-patient study, to assess a treatment option for a case of a recurrent methicillin-susceptible E. faecium infection in a prosthetic hip joint. The patient has repeatedly failed standard of care medical and surgical management.
Given the severity and chronicity of E. faecium infection and burden of infected hardware, the only option to achieve surgical source control would involve an aggressive, high risk surgical approach: a high amputation of the left leg to remove infected hardware and peri-implant bone and tissues. In the absence of any viable adjunctive antimicrobial therapy, this patient is at high risk of mortality and morbidity. It is therefore paramount that we explore alternative treatment modalities for the management of this infection, such as bacteriophage (phage) therapy.
The primary objective of this study is to investigate the preliminary efficacy, safety, and tolerability of systemic (intravenous) and intra-articular administration of a lytic phage (in our patient with chronic E. faecium PJI.
Secondary objectives will be documenting clinical changes pre- and post-therapy, as well as identifying adjunctive changes in biomarkers (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], and interleukin-6 [IL-6]) correlated with PJI as well as phage titres.
In this study, lytic phage prepared in injection-grade saline will be administered to the patient both intravenously and intraarticularly, twice a day for a duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.
The patient will remain in clinical follow-up for up to one year.
- Conditions
- Periprosthetic Joint Infection
- Being tested
- Phage Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phage TherapyBiological
Our phage is an investigational treatment for bacterial infections. Our lytic phage preparation was provided by Cytophage Technologies (CIP-200).
| Study group | Role | What they receive |
|---|---|---|
| Phage Therapy | Experimental | Lytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: a) intravenously twice daily, and concomitantly, b) intra-articularly twice daily, for a total duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy. Receives: Biological: Phage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of phage therapy
Reactions and adverse events to the treatment
Measured: Day 0 to 1 year from treatment
Efficacy of phage therapy
No recurrence of the infection
Measured: 1 Year
Tolerability of phage therapy
Reactions and adverse events to the intravenous and intra-articular administration
Measured: Day 0 to Day 13 of treatment
Secondary outcomes (4)
Changes in biomarkers (C-reactive protein)
Serum C-reactive protein (mg/L) as measured at baseline
Measured: Day 0 to 1 year from treatment
Changes in biomarkers (erythrocyte sedimentation rate)
Serum erythrocyte sedimentation rate (mm/hr) as measured at baseline
Measured: Day 0 to 1 year from treatment
Changes in biomarkers (interleukin-6)
Serum interleukin-6 (pg/mL) as measured at baseline
Measured: Day 0 to 1 year from treatment
Changes in biomarkers (phage titres)
Phage particles present in a given volume of liquid (PFU/mL)
Measured: Day 0 to Day 13 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: * intravenously twice daily, and concomitantly, * intra-articularly twice daily, for a total duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Innovation Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cytophage Technologies Inc., Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- David Hedden, MD, Principal investigator, Concordia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942624
- Sponsor's protocol ID
- OIC-Phage-2025-01
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phage Therapy for the Treatment of a Chronic Enterococcus Faecium Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT06942624
- Acronym / sponsor ID
- OIC-Phage-2025-01
- Conditions
- Periprosthetic Joint Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Orthopaedic Innovation CentreUniversity, hospital or other
- Collaborators
- Cytophage Technologies Inc., Ottawa Hospital Research Institute
- Study start
- May 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Apr 2025 (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.
This purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of a bacteriophage therapy in a patient with a methicillin-susceptible Enterococcus faecium (E. faecium) prosthetic joint infection (PJI) of the hip. We have exhausted all surgical and medical management of PJI for our patient.
The phage will be administered to the study patient during a 14 days period via intravenous and intra-articular. The patient will be monitored in clinic for up to 1 year.
Detailed description
This is a single-patient study, to assess a treatment option for a case of a recurrent methicillin-susceptible E. faecium infection in a prosthetic hip joint. The patient has repeatedly failed standard of care medical and surgical management.
Given the severity and chronicity of E. faecium infection and burden of infected hardware, the only option to achieve surgical source control would involve an aggressive, high risk surgical approach: a high amputation of the left leg to remove infected hardware and peri-implant bone and tissues. In the absence of any viable adjunctive antimicrobial therapy, this patient is at high risk of mortality and morbidity. It is therefore paramount that we explore alternative treatment modalities for the management of this infection, such as bacteriophage (phage) therapy.
The primary objective of this study is to investigate the preliminary efficacy, safety, and tolerability of systemic (intravenous) and intra-articular administration of a lytic phage (in our patient with chronic E. faecium PJI.
Secondary objectives will be documenting clinical changes pre- and post-therapy, as well as identifying adjunctive changes in biomarkers (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], and interleukin-6 [IL-6]) correlated with PJI as well as phage titres.
In this study, lytic phage prepared in injection-grade saline will be administered to the patient both intravenously and intraarticularly, twice a day for a duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.
The patient will remain in clinical follow-up for up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: * intravenously twice daily, and concomitantly, * intra-articularly twice daily, for a total duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.
| Arm | Type | Receives |
|---|---|---|
| Phage Therapy | Experimental | Biological: Phage TherapyLytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: a) intravenously twice daily, and concomitantly, b) intra-articularly twice daily, for a total duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- This N-of-1 Phage therapy is designed for one patient who meet the following conditions
- Willingness to provide signed and dated informed consent form to participate in the clinical study
- Chronic prosthetic joint infection
- History of multiple surgical and medication managements with no success
Key exclusion criteria (1 listed)
- below 18 years of age
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 |
|---|---|---|
| Phage TherapyOur phage is an investigational treatment for bacterial infections. Our lytic phage preparation was provided by Cytophage Technologies (CIP-200). | Biological | Phage Therapy |
Primary outcome
Safety of phage therapy
Time frame: Day 0 to 1 year from treatment
Reactions and adverse events to the treatment
Efficacy of phage therapy
Time frame: 1 Year
No recurrence of the infection
Tolerability of phage therapy
Time frame: Day 0 to Day 13 of treatment
Reactions and adverse events to the intravenous and intra-articular administration
4 secondary outcomes
Changes in biomarkers (C-reactive protein)
Time frame: Day 0 to 1 year from treatment
Changes in biomarkers (erythrocyte sedimentation rate)
Time frame: Day 0 to 1 year from treatment
Changes in biomarkers (interleukin-6)
Time frame: Day 0 to 1 year from treatment
Changes in biomarkers (phage titres)
Time frame: Day 0 to Day 13 of 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 24 Apr 2025.
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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.
David Hedden, MD principal investigator
Concordia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phage Therapy in people with Periprosthetic Joint Infection, run by Orthopaedic Innovation Centre at 1 site in Canada.
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 4 inclusion and 1 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 24 Apr 2025. 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sarah Tran (204-926-1231, stran@orthoinno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of phage therapy (time frame: Day 0 to 1 year from treatment). The study lists 3 primary outcomes in all. 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 24 Apr 2025.