Active — Not RecruitingPhase 1

Use of Phage Therapy for Treatment of a Periprosthetic Joint Infection

Canada1 participantsStarted 2024-02-22

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety of phage therapy

Timeframe: From first day to 12 months from treatment

Efficacy of phage therapy (clinical response)

Timeframe: 1 year

Trial details

NCT IDNCT06827041

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02