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Use of Phage Therapy for Treatment of a Periprosthetic Joint Infection
Sponsor: Ottawa Hospital Research Institute
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
Official title: Use of Phage Therapy for Treatment of a Life-Threatening, Multidrug Resistant Staphylococcus Epidermidis Chronic Periprosthetic Joint Infection: an N-of-1 Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1
Start Date
2024-02-22
Completion Date
2025-02
Last Updated
2025-02-14
Healthy Volunteers
No
Conditions
Interventions
Phage (Cytophage Technologies)
Our phage is a new type of investigational treatment for bacterial infections. Our lytic, monophage preparation was provided by Cytophage Technologies and underwent rigorous testing to ensure final product potency (7 x 10\^9 PFU/dose), purity, fidelity, and safety; laboratory tests demonstrate phage in vitro efficacy against the S. epidermidis strain. Phage prepared in injection-grade saline will be given via two routes: a) intravenously twice daily, and concomitantly, b) intraarticularly twice daily, for a total duration of 14 days.
Locations (1)
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada