"Debridement PhagE AnTibiotics for PJI"
Starting soon · Phase 2/Phase 3
Conditions studied: Periprosthetic Infection
In brief
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.
Key facts
- Study ID
- NCT07698002
- Run by
- Ottawa Hospital Research Institute
- People needed
- 10
- Starts
- 2026-07-02
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ottawa Hospital Research Institute — Ottawa, Canada
Full record on ClinicalTrials.gov
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