Clinical study
BPhage
Use of Phage Therapy for Treatment of a Periprosthetic Joint Infection
| Status | Active, not recruiting |
|---|---|
| Type | Individual-case protocol |
| Countries | Canada |
| Conditions studied | Periprosthetic Joint Infection |
| Study years | 2024–2025 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
Inclusion Criteria: 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. * severe chronic periprosthetic joint infection due to a multidrug resistant strain of S. epidermidis in which surgical source control with complete removal of implants cannot be safely achieved * have received multiple surgical revisions with complex reconstructions and adjunctive flap coverage procedures and prolonged courses of antibiotic therapy and suffered multiple, severe antibiotic allergic reactions during initial treatment course which has lead to the use of any viable suppressive therapy impossible * complex burden of hardware * poor bone quality and hip instability with high associated morbidity and mortality due to the S. epidermidis infection Exclusion Criteria: \- below age 18 years
Study description
The goal of this clinical trial is to learn about the safety, tolerability and activity or efficacy of systemic intravenous and intraarticular administration of a mono-bacteriophage (phage) peparation in a patient with chronic-recalcitrant methicillin-resistant Staphylococcus epidermidis (MRSE) periprosthetic joint infection (PJI) and also to understand 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. Phage will be administered to the study participant with chronic PJI twice daily over a total duration of two weeks via two routes: a) intravenous (through vein) and b) intra-articular (through the affected joint). Phage therapy is given 4 hours after the patient receives their standard of care antibiotic therapy. The patient will remain in clinical follow-up for up to a year.1
Study registrations
| ClinicalTrials.gov | NCT06827041 |
|---|
Recorded study locations (1)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Recorded site status: Not separately listed. Study location source ↗
Related programs(1)
The Ottawa Hospital / OHRI implant infection phage research
Intake unconfirmed
Recorded program–study link. Website
Notes from the source review
- Single-patient protocol (target/actual n=1); not a broad recruiting program. Planned completion date has passed while registry status remains nonterminal; recheck with site.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct06827041 |
|---|