Periprosthetic InfectionPhase 2/3DePHEAT-PJINCT07698002
"Debridement PhagE AnTibiotics for PJI"
A Phase 2/3 study testing The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages. in people with Periprosthetic Infection, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Total joint replacement (TJR) has revolutionized care provided for patients suffering from disabling joint pain. Unfortunately, periprosthetic joint infection (PJI) remains a devastating complication and the leading cause of failure after TJR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Infection
- What is being tested?
- The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jul 2026to 1 Aug 2028
- Phase
- Phase 2/3
- 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
- Patients are 18 years or older
- Patients have been diagnosed with bacterial PJI caused by a single organism (either S. aureus or P. aeruginosa) confirmed through synovial fluid cultures.
- Patients are undergoing DAIR surgical procedure for hip or knee PJI
- Patients are clinically stable and independently mobile
- Patients are willing and able to consent
Who cannot join
- Patients have cultured multiple bacteria, and it is difficult for physicians to determine which bacteria is causing the disease
- Patients develop a life-threatening condition or a condition that leads to deterioration of the patient's medical condition and that is unrelated to the known PJI as cerebrovascular accident, angina, cancer.
- Patient's clinical condition is no longer stable and deteriorating, for example, if the patient develops sepsis secondary to PJI prior to the commencement of the phage therapy.
- Patients who have only been through a hemiarthroplasty or uni-compartmental arthroplasty with infected implant component
- Patients receiving any immunomodulating or immunosuppressive therapy medications for malignancy or autoimmune disease (with exception to inflammatory arthritis), chronic glucocorticoid use (≥ 20mg of prednisolone daily for at least 1 month with another cause of immunosuppression), and history of solid organ and/or bone marrow transplantation.
- Presence of concurrent active viral infection, or history of uncontrolled HIV (CD4 count <200 cells/uL).
- Patient is pregnant or breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Feasibility Clinical Trial of Phage Therapy in Periprosthetic Joint Infections Treated With Debridement Antibiotic Implant Retention (DAIR) Procedure.
Total joint replacement (TJR) has revolutionized care provided for patients suffering from disabling joint pain. Unfortunately, periprosthetic joint infection (PJI) remains a devastating complication and the leading cause of failure after TJR. Current standard treatment for PJI requires multiple surgical revisions of the infected prosthesis in combination with a prolonged course of systemic antibiotic therapy. Debridement Antibiotic and Implant Retention (DAIR) procedure is one of the surgical options that is routinely used to manage PJI, due to its lower risk of morbidity and surgical cost. DAIR is often used for patients who present with an acute PJI or who cannot tolerate a complex implant revision. However, the overall success rate for DAIR is ranging between 60-70%. DAIR failures are often attributed to the residual infection and biofilm burden left behind on the retained implant surface, which cannot be targeted effectively with post-operative systemic antibiotics. Therefore, research has been ongoing to identify non-surgical multidrug resistance (MDR) treatment adjuncts that can synergize the therapeutic effects of antibiotics in PJI care.
Numerous preclinical bone and joint infection models have clearly demonstrated such therapeutic benefits using bacteriophages (phages). Phages target bacterial cells and breakdown biofilm that it forms on the implant surface. Each bacterial strain tends to have a particular phage that is susceptible to that bacterial strain. Due to this phage specificity and the fact that bacteria can still develop resistance against a single phage, the concept of using a phage cocktail (mixture of 2 or more phage candidates) has been the preferred treatment approach for applying phage therapy. Using a phage cocktail provides a broader spectrum of bacterial strain coverage and makes it harder for the bacteria to develop resistance. Published literature has considered phage therapy to be safe for direct administration at the infection site with minimal adverse events provided that the phage preparation administered meets Good Manufacturing Practice (GMP).
Read more
The DePHEAT PJI trail, is a prospective, single center, 1:1 non-blinded feasibility randomized controlled trial (RCT) that aims to assess the safety and the effectiveness of the experimental phage therapy cocktails for patients with hip or knee PJI caused by either Staphylococcus (S.) aureus or Pseudomonas (P.) aeruginosa and comparing it to standardized therapy.
The investigator hypothesizes that this pilot RCT will help evaluate the practicality and potential risks associated with adding phage therapy to the conventional standard of care treatment plan. This will initiate the development of a necessary infrastructure for future phage trials and programs that expand our understanding on the benefits of using phage therapy for acute PJI.
Read the detailed description
Total joint replacement (TJR) has revolutionized care provided for patients suffering from disabling joint pain. Unfortunately, periprosthetic joint infection (PJI) remains a devastating complication and the leading cause of failure after TJR. While the current cost in Canada per hip or knee TJR averages $7k CAD, the cost to treat a PJI complication after a hip or knee TJR is five times that amount. In addition, data collected by national and international joint replacement registries demonstrate that the health and economic burden of PJI is a mounting crisis due to the exponential increase in demand for TJR. Current standard treatment for PJI requires multiple surgical revisions of the infected prosthesis in combination with a prolonged course of systemic antibiotic therapy. This standard treatment approach has a failure rate of 20-30%. Unfortunately, this treatment failure is often associated with high rates of psychological distress, limb amputations and death. Debridement Antibiotic and Implant Retention (DAIR) procedure is one of the surgical options that is routinely used to manage PJI, due to its lower risk of morbidity and surgical cost. DAIR is often used for patients who present with an acute PJI or who cannot tolerate a complex implant revision. However, the overall success rate for DAIR is at the lower end of the spectrum, ranging between 60-70%. DAIR failures are often attributed to the residual infection and biofilm burden left behind on the retained implant surface, which cannot be targeted effectively with post-operative systemic antibiotics. Therefore, research has been ongoing to identify non-surgical multidrug resistance (MDR) treatment adjuncts that can synergize the therapeutic effects of antibiotics in PJI care.
Numerous preclinical bone and joint infection models have clearly demonstrated such therapeutic benefits using bacteriophages (phages). Phages target bacterial cells and breakdown biofilm that it forms on the implant surface. Each bacterial strain tends to have a particular phage that is susceptible to that bacterial strain. Due to this phage specificity and the fact that bacteria can still develop resistance against a single phage, the concept of using a phage cocktail (mixture of 2 or more phage candidates) has been the preferred treatment approach for applying phage therapy. Using a phage cocktail provides a broader spectrum of bacterial strain coverage and makes it harder for the bacteria to develop resistance. Over the past decade, there has been a rise in international interest and effort to translate the antimicrobial therapeutic potential of phages towards this challenging group of patients suffering from bone and joint infections. Published literature has considered phage therapy to be safe for direct administration at the infection site with minimal adverse events provided that the phage preparation administered meets Good Manufacturing Practice (GMP).
The overarching purpose of this trial is to assess the feasibility, safety and effectiveness of phage therapy in patients with hip or knee PJI. The investigators hypothesize that this pilot RCT will help evaluate the practicality and potential risks associated with adding phage therapy to the conventional standard of care treatment plan. This will initiate the development of a necessary infrastructure for future phage trials and programs that expand our understanding on the benefits of using phage therapy for acute PJI.
- Conditions
- Periprosthetic Infection
- Being tested
- The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages.
- Keywords
- Phage therapy, Periprosthetic Joint Infection, Bacteriophage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages.Biological
Also called Bacteriophage therapy
For participants randomized to the intervention arm will receive a total of 3 local administrations (intra-articular) of the appropriate phage cocktail to the infected joint. The first dose will be administered intraoperatively during the DAIR procedure after closing the joint capsule. The second dose will be administered on post-operative days (POD) 14 and the third dose will be administered POD 21. The second and third doses will be administered by interventional radiology using image guidance (fluoroscopy) as per standard drug administration.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (DAIR + Antibiotics) | No intervention | Patients will receive the standard of care for hip and knee periprosthetic joint infection which is DAIR ( Debridement Antibiotic and Implant Retention) and antibiotic according to the bacterial culture. |
| Bacteriophage treatment + DAIR + Antibiotics | Experimental | In addition to the standard of care procedure (DAIR and antibiotics), patients in the experimental arm will receive 3 doses of intra-articular phage therapy. The first dose will be given intra-operatively after the DAIR and then will be done at day 14 and day 21 postoperatively. The second and third intra-articular injections will be done under image guidance. Receives: Biological: The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse event
focuses on documenting any adverse events (both transient and persistent) or reactions associated with phage therapy.
- Monitoring for signs and symptoms of allergic reactions after each phage administration, which could be manifested as fever, rash, flushing, hypotension
- Monitoring for any signs and symptoms of emerging new infections
- Monitoring for emergence of resistance to phage therapy or to antibiotics
Measured: up to 12 months
Evaluation of the feasibility of the trial design
To assess the practical aspect of administering phage therapy in a hospital setting. This trial will define the achievability of performing a future larger scale trial. This trial will be evaluating the following:
- logistical challenges related to transportation, storage and handling of phage therapy
- operational challenges including technical and time feasibility factors
- patient recruitment and acceptance to participating in such a trial
Measured: up to 3 months
Secondary outcomes (3)
Assessment of clinical response effectiveness to phage therapy
Clinical effectiveness would be assessed through
- Functional and mobility assessments during the study period using Patient Reported Outcome Measures (PROMS) and clinical examination of participants range of motion compared to the baseline.
- The absence of the need for re-interventions and repetitive debridement
Measured: up to 12 months
Assessment of Microbiological effectiveness of phage therapy
Microbiological effectiveness includes the absence of isolated bacterial culture after phage therapy treatment.
Measured: up to 12 months
Assessment of biochemical effectiveness of the phage therapy
Monitoring of the serum inflammatory markers compared to the baseline
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start2 Jul 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot 1:1 non blinded randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesham Abdelbary, MD MSc FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698002
- Sponsor's protocol ID
- DePHEAT PJI
- Acronym
- DePHEAT-PJI
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information about study participants will be kept confidential and managed according to the requirements of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. All personal health information will be kept confidential, unless release is required by law. Representatives of government regulators such as Health Canada, representatives of The Ottawa Hospital Research Ethics Board (OHSN-REB) as well as the Ottawa Hospital Research Institute may review the original, relevant medical records under the supervision of the QI and the study team for monitoring and auditing purposes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility Clinical Trial of Phage Therapy in Periprosthetic Joint Infections Treated With Debridement Antibiotic Implant Retention (DAIR) Procedure.
- ClinicalTrials.gov ID
- NCT07698002
- Acronym / sponsor ID
- DePHEAT-PJI / DePHEAT PJI
- Conditions
- Periprosthetic Infection
- Keywords
- Phage therapy, Periprosthetic Joint Infection, Bacteriophage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 2 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 13 Jul 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.
Total joint replacement (TJR) has revolutionized care provided for patients suffering from disabling joint pain. Unfortunately, periprosthetic joint infection (PJI) remains a devastating complication and the leading cause of failure after TJR. Current standard treatment for PJI requires multiple surgical revisions of the infected prosthesis in combination with a prolonged course of systemic antibiotic therapy. Debridement Antibiotic and Implant Retention (DAIR) procedure is one of the surgical options that is routinely used to manage PJI, due to its lower risk of morbidity and surgical cost. DAIR is often used for patients who present with an acute PJI or who cannot tolerate a complex implant revision. However, the overall success rate for DAIR is ranging between 60-70%. DAIR failures are often attributed to the residual infection and biofilm burden left behind on the retained implant surface, which cannot be targeted effectively with post-operative systemic antibiotics. Therefore, research has been ongoing to identify non-surgical multidrug resistance (MDR) treatment adjuncts that can synergize the therapeutic effects of antibiotics in PJI care.
Numerous preclinical bone and joint infection models have clearly demonstrated such therapeutic benefits using bacteriophages (phages). Phages target bacterial cells and breakdown biofilm that it forms on the implant surface. Each bacterial strain tends to have a particular phage that is susceptible to that bacterial strain. Due to this phage specificity and the fact that bacteria can still develop resistance against a single phage, the concept of using a phage cocktail (mixture of 2 or more phage candidates) has been the preferred treatment approach for applying phage therapy. Using a phage cocktail provides a broader spectrum of bacterial strain coverage and makes it harder for the bacteria to develop resistance. Published literature has considered phage therapy to be safe for direct administration at the infection site with minimal adverse events provided that the phage preparation administered meets Good Manufacturing Practice (GMP).
The DePHEAT PJI trail, is a prospective, single center, 1:1 non-blinded feasibility randomized controlled trial (RCT) that aims to assess the safety and the effectiveness of the experimental phage therapy cocktails for patients with hip or knee PJI caused by either Staphylococcus (S.) aureus or Pseudomonas (P.) aeruginosa and comparing it to standardized therapy.
The investigator hypothesizes that this pilot RCT will help evaluate the practicality and potential risks associated with adding phage therapy to the conventional standard of care treatment plan. This will initiate the development of a necessary infrastructure for future phage trials and programs that expand our understanding on the benefits of using phage therapy for acute PJI.
Detailed description
Total joint replacement (TJR) has revolutionized care provided for patients suffering from disabling joint pain. Unfortunately, periprosthetic joint infection (PJI) remains a devastating complication and the leading cause of failure after TJR. While the current cost in Canada per hip or knee TJR averages $7k CAD, the cost to treat a PJI complication after a hip or knee TJR is five times that amount. In addition, data collected by national and international joint replacement registries demonstrate that the health and economic burden of PJI is a mounting crisis due to the exponential increase in demand for TJR. Current standard treatment for PJI requires multiple surgical revisions of the infected prosthesis in combination with a prolonged course of systemic antibiotic therapy. This standard treatment approach has a failure rate of 20-30%. Unfortunately, this treatment failure is often associated with high rates of psychological distress, limb amputations and death. Debridement Antibiotic and Implant Retention (DAIR) procedure is one of the surgical options that is routinely used to manage PJI, due to its lower risk of morbidity and surgical cost. DAIR is often used for patients who present with an acute PJI or who cannot tolerate a complex implant revision. However, the overall success rate for DAIR is at the lower end of the spectrum, ranging between 60-70%. DAIR failures are often attributed to the residual infection and biofilm burden left behind on the retained implant surface, which cannot be targeted effectively with post-operative systemic antibiotics. Therefore, research has been ongoing to identify non-surgical multidrug resistance (MDR) treatment adjuncts that can synergize the therapeutic effects of antibiotics in PJI care.
Numerous preclinical bone and joint infection models have clearly demonstrated such therapeutic benefits using bacteriophages (phages). Phages target bacterial cells and breakdown biofilm that it forms on the implant surface. Each bacterial strain tends to have a particular phage that is susceptible to that bacterial strain. Due to this phage specificity and the fact that bacteria can still develop resistance against a single phage, the concept of using a phage cocktail (mixture of 2 or more phage candidates) has been the preferred treatment approach for applying phage therapy. Using a phage cocktail provides a broader spectrum of bacterial strain coverage and makes it harder for the bacteria to develop resistance. Over the past decade, there has been a rise in international interest and effort to translate the antimicrobial therapeutic potential of phages towards this challenging group of patients suffering from bone and joint infections. Published literature has considered phage therapy to be safe for direct administration at the infection site with minimal adverse events provided that the phage preparation administered meets Good Manufacturing Practice (GMP).
The overarching purpose of this trial is to assess the feasibility, safety and effectiveness of phage therapy in patients with hip or knee PJI. The investigators hypothesize that this pilot RCT will help evaluate the practicality and potential risks associated with adding phage therapy to the conventional standard of care treatment plan. This will initiate the development of a necessary infrastructure for future phage trials and programs that expand our understanding on the benefits of using phage therapy for acute PJI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot 1:1 non blinded randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Standard of care (DAIR + Antibiotics) | No intervention | –Patients will receive the standard of care for hip and knee periprosthetic joint infection which is DAIR ( Debridement Antibiotic and Implant Retention) and antibiotic according to the bacterial culture. |
| Bacteriophage treatment + DAIR + Antibiotics | Experimental | Biological: The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages.In addition to the standard of care procedure (DAIR and antibiotics), patients in the experimental arm will receive 3 doses of intra-articular phage therapy. The first dose will be given intra-operatively after the DAIR and then will be done at day 14 and day 21 postoperatively. The second and third intra-articular injections will be done under image guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are 18 years or older
- Patients have been diagnosed with bacterial PJI caused by a single organism (either S. aureus or P. aeruginosa) confirmed through synovial fluid cultures.
- Patients are undergoing DAIR surgical procedure for hip or knee PJI
- Patients are clinically stable and independently mobile
- Patients are willing and able to consent
Key exclusion criteria (7 listed)
- Patients have cultured multiple bacteria, and it is difficult for physicians to determine which bacteria is causing the disease
- Patients develop a life-threatening condition or a condition that leads to deterioration of the patient's medical condition and that is unrelated to the known PJI as cerebrovascular accident, angina, cancer.
- Patient's clinical condition is no longer stable and deteriorating, for example, if the patient develops sepsis secondary to PJI prior to the commencement of the phage therapy.
- Patients who have only been through a hemiarthroplasty or uni-compartmental arthroplasty with infected implant component
- Patients receiving any immunomodulating or immunosuppressive therapy medications for malignancy or autoimmune disease (with exception to inflammatory arthritis), chronic glucocorticoid use (≥ 20mg of prednisolone daily for at least 1 month with another cause of immunosuppression), and history of solid organ and/or bone marrow transplantation.
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 |
|---|---|---|
| The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages.Also: Bacteriophage therapyFor participants randomized to the intervention arm will receive a total of 3 local administrations (intra-articular) of the appropriate phage cocktail to the infected joint. The first dose will be administered intraoperatively during the DAIR procedure after closing the joint capsule. The second dose will be administered on post-operative days (POD) 14 and the third dose will be administered POD 21. The second and third doses will be administered by interventional radiology using image guidance (fluoroscopy) as per standard drug administration. | Biological | Bacteriophage treatment + DAIR + Antibiotics |
Primary outcome
Incidence of treatment emergent adverse event
Time frame: up to 12 months
focuses on documenting any adverse events (both transient and persistent) or reactions associated with phage therapy. * Monitoring for signs and symptoms of allergic reactions after each phage administration, which could be manifested as fever, rash, flushing, hypotension * Monitoring for any signs and symptoms of emerging new infections * Monitoring for emergence of resistance to phage therapy or to antibiotics
Evaluation of the feasibility of the trial design
Time frame: up to 3 months
To assess the practical aspect of administering phage therapy in a hospital setting. This trial will define the achievability of performing a future larger scale trial. This trial will be evaluating the following: * logistical challenges related to transportation, storage and handling of phage therapy * operational challenges including technical and time feasibility factors * patient recruitment and acceptance to participating in such a trial
3 secondary outcomes
Assessment of clinical response effectiveness to phage therapy
Time frame: up to 12 months
Assessment of Microbiological effectiveness of phage therapy
Time frame: up to 12 months
Assessment of biochemical effectiveness of the phage therapy
Time frame: Up to 12 months
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 13 Jul 2026.
- Individual participant dataSharing planned: No. Information about study participants will be kept confidential and managed according to the requirements of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. All personal health information will be kept confidential, unless release is required by law. Representatives of government regulators such as Health Canada, representatives of The Ottawa Hospital Research Ethics Board (OHSN-REB) as well as the Ottawa Hospital Research Institute may review the original, relevant medical records under the supervision of the QI and the study team for monitoring and auditing purposes
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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.
Hesham Abdelbary, MD MSc FRCSC principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing The investigational product specifically targeting P. aeruginosa (DP-QB-PSA-005) and that targeting S. aureus (DP-QB-STA-005), each formed of a mixture of 5 bacteriophages. in people with Periprosthetic Infection, run by Ottawa Hospital Research Institute 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 5 inclusion and 7 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 13 Jul 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Incidence of treatment emergent adverse event (time frame: up to 12 months). The study lists 2 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 13 Jul 2026.