Prosthetic Joint Infections of HipPhase 1/2PHAGE-MOM-001NCT06814756
Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection
A Phase 1/2 study testing phage therapy in people with Prosthetic Joint Infections of Hip, 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 drug product to treat and prevent the recurrence of a Morganella morganii prosthetic joint infection of the hip. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prosthetic Joint Infections of Hip
- 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
- 26 Mar 2025to Mar 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 Any age
- Women 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 drug product to treat and prevent the recurrence of a Morganella morganii prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. The treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area 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.
- Conditions
- Prosthetic Joint Infections of Hip
- Being tested
- phage therapy
- Keywords
- Bacteriophage, Periprosthetic joint infection, Phage therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phage therapyBiological
Single anti-Morganella morganii bacteriophage drug product
| Study group | Role | What they receive |
|---|---|---|
| Open Label Arm | Experimental | Bacteriophage drug product Receives: Biological: phage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response to phage therapy as determined by participant's absence of physical symptoms
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 (1)
Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events
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 bloodwork to detect any potential organ damage or unexpected side effects.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start26 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (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.
- More trials run by University of CalgaryThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single patient
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Qeen Biotechnologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814756
- Sponsor's protocol ID
- REB25-0157
- Acronym
- PHAGE-MOM-001
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 12 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT06814756
- Acronym / sponsor ID
- PHAGE-MOM-001 / REB25-0157
- Conditions
- Prosthetic Joint Infections of Hip
- Keywords
- Bacteriophage, Periprosthetic joint infection, Phage therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Qeen Biotechnologies
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Feb 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 is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage drug product to treat and prevent the recurrence of a Morganella morganii prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. The treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area 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.
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 drug product |
Who may qualify
- Sex
- Female 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 therapySingle anti-Morganella morganii bacteriophage drug product | Biological | Open Label Arm |
Primary outcome
Clinical response to phage therapy as determined by participant's absence of physical symptoms
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.
1 secondary outcome
Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events
Time frame: 29 days
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 12 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, 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 12 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 to phage therapy as determined by participant's absence of physical symptoms (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 12 Jun 2025.