Prosthetic Joint Infections of HipPhase 1/2PHAGE-2024-01NCT06456424
Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection
A Phase 1/2 study testing Phage therapy in people with Prosthetic Joint Infections of Hip and Staphylococcus Aureus Infection, run by University of Calgary at 1 site in Canada.
Trial summary
This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prosthetic Joint Infections of Hip, Staphylococcus Aureus Infection
- What is being tested?
- Phage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2024to Nov 2025
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of active chronic prosthetic joint infection
- Causative bacteria is susceptible to bacteriophage therapy in vitro
- History of multiple failed antibiotic and surgical interventions
Who cannot join
- Stage 5 chronic kidney disease
- Cirrhosis
- A known allergy to phage products
- Fever
- Involvement in another clinical trial
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to his quality of life. The treatment involves a one time, intra-operative injection of bacteriophages into the joint and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.
Read the detailed description
This study is a single-patient, phase I/II clinical trial that addresses a challenging case of a recurrent methicillin-sensitive Staphylococcus aureus (MSSA) infection in a prosthetic hip joint despite extensive antibiotic treatments and multiple surgeries.
Given the failure of conventional treatments and the high risk associated with major surgical interventions, this study explores the use of bacteriophage therapy as an innovative alternative. Bacteriophages, viruses that specifically infect and lyse bacterial cells, offer a patient-specific, targeted approach to combating bacterial infections within biofilms. Our study will use a bacteriophage cocktail containing phages BP13 and J1P3, both of which have demonstrated in-vitro activity against the patient's strain of S. aureus.
The treatment protocol involves the administration of phages intra-articularly on day 1 and intravenously twice daily on days 1-14. This dual approach aims to enhance the efficacy of the phage therapy by ensuring both systemic and localized delivery of the phages to the infected site.
The primary outcome will be the resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever, as well as the normalization of inflammatory markers over a 12-month period following the phage therapy.
Throughout the study, the patient's safety and response to the treatment will be rigorously monitored through regular physical examinations, blood tests, and if needed, imaging studies. The initial dose of the phage cocktail will be administered in a hospital setting to monitor for any immediate adverse reactions Follow-up assessments will continue for a year to ensure long-term efficacy and safety.
The goal of this study is to demonstrate the potential of bacteriophage therapy as a viable treatment option for prosthetic joint infections, particularly those resistant to standard treatments. Success in this case could pave the way for broader applications of phage therapy in managing complex bacterial infections, offering a new avenue for treatment where traditional methods have failed.
- Being tested
- Phage therapy
- Keywords
- Single patient, Bacteriophage, Phage
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phage therapyBiological
Bacteriophage cocktail consisting of phages BP13 and J1P3
| Study group | Role | What they receive |
|---|---|---|
| Open Label Arm | Experimental | Bacteriophage cocktail Receives: Biological: Phage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever. This will be determined by a questionnaire and monthly assessments by a Infectious Disease physician.
Measured: 1 year
Secondary outcomes (3)
Safety of phage therapy
The safety outcome focuses on monitoring and documenting any adverse events (both serious and not) or reactions associated with bacteriophage therapy. Key safety measures include observing for immediate allergic reactions during the first dose, conducting regular clinical assessments, and performing routine blood tests (complete blood counts, lymphocyte subsets, c-reactive protein, liver function tests, serum electrolytes and serum creatinine) to detect any potential organ damage or unexpected side effects.
Measured: 29 days
Microbiologic response
Bacterial cultures from the infected joint will be sent on an as-needed basis should the patient develop another draining fistula or require a repeat surgical incision and drainage. If there is no need to send bacterial cultures, or if bacteria other than Staphylococcus aureus are isolated, then this would be a good microbiologic response.
Measured: 1 year
Biochemical response
To monitor for subclinical infection the patient will have serum inflammatory markers (white blood cell count and c-reactive protein) sent on days 0, 2, 4, 8, 11, 15, 29, and then every 30 days afterwards. Should both inflammatory markers decrease to be within the normal limits this would be a good biochemical response.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start20 Nov 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint Infections of HipStudies 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
- Single patient
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Precisio Biotix Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456424
- Sponsor's protocol ID
- REB23-1733
- Other IDs
- Control #: 286405, Dossier ID: HC6-024-c283712
- Acronym
- PHAGE-2024-01
- Status last verified
- Jun 2025
- First submitted
- 29 May 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT06456424
- Acronym / sponsor ID
- PHAGE-2024-01 / REB23-1733
- Keywords
- Single patient, Bacteriophage, Phage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Toronto, Precisio Biotix Therapeutics, Inc.
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 13 Jun 2024 (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 is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to his quality of life. The treatment involves a one time, intra-operative injection of bacteriophages into the joint and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.
Detailed description
This study is a single-patient, phase I/II clinical trial that addresses a challenging case of a recurrent methicillin-sensitive Staphylococcus aureus (MSSA) infection in a prosthetic hip joint despite extensive antibiotic treatments and multiple surgeries.
Given the failure of conventional treatments and the high risk associated with major surgical interventions, this study explores the use of bacteriophage therapy as an innovative alternative. Bacteriophages, viruses that specifically infect and lyse bacterial cells, offer a patient-specific, targeted approach to combating bacterial infections within biofilms. Our study will use a bacteriophage cocktail containing phages BP13 and J1P3, both of which have demonstrated in-vitro activity against the patient's strain of S. aureus.
The treatment protocol involves the administration of phages intra-articularly on day 1 and intravenously twice daily on days 1-14. This dual approach aims to enhance the efficacy of the phage therapy by ensuring both systemic and localized delivery of the phages to the infected site.
The primary outcome will be the resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever, as well as the normalization of inflammatory markers over a 12-month period following the phage therapy.
Throughout the study, the patient's safety and response to the treatment will be rigorously monitored through regular physical examinations, blood tests, and if needed, imaging studies. The initial dose of the phage cocktail will be administered in a hospital setting to monitor for any immediate adverse reactions Follow-up assessments will continue for a year to ensure long-term efficacy and safety.
The goal of this study is to demonstrate the potential of bacteriophage therapy as a viable treatment option for prosthetic joint infections, particularly those resistant to standard treatments. Success in this case could pave the way for broader applications of phage therapy in managing complex bacterial infections, offering a new avenue for treatment where traditional methods have failed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single patient
| Arm | Type | Receives |
|---|---|---|
| Open Label Arm | Experimental | Biological: Phage therapyBacteriophage cocktail |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of active chronic prosthetic joint infection
- Causative bacteria is susceptible to bacteriophage therapy in vitro
- History of multiple failed antibiotic and surgical interventions
Key exclusion criteria (6 listed)
- Stage 5 chronic kidney disease
- Cirrhosis
- A known allergy to phage products
- Fever
- Involvement in another clinical trial
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 therapyBacteriophage cocktail consisting of phages BP13 and J1P3 | Biological | Open Label Arm |
Primary outcome
Clinical response
Time frame: 1 year
Resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever. This will be determined by a questionnaire and monthly assessments by a Infectious Disease physician.
3 secondary outcomes
Safety of phage therapy
Time frame: 29 days
Microbiologic response
Time frame: 1 year
Biochemical response
Time frame: 1 year
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 11 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Prosthetic Joint Infections of Hip and Staphylococcus Aureus Infection, run by University of Calgary 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: 1 year). 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 11 Jun 2025.