This purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of a bacteriophage therapy in a patient with a methicillin-susceptible Enterococcus faecium (E. faecium) prosthetic joint infection (PJI) of the hip. We have exhausted all surgical and medical management of PJI for our patient.
The phage will be administered to the study patient during a 14 days period via intravenous and intra-articular. The patient will be monitored in clinic for up to 1 year.
Willingness to provide signed and dated informed consent form to participate in the clinical study
Chronic prosthetic joint infection
History of multiple surgical and medication managements with no success
below 18 years of age
Single group
Phage Therapy
Biological/VaccineOur phage is an investigational treatment for bacterial infections. Our lytic phage preparation was provided by Cytophage Technologies (CIP-200).
Safety of phage therapy
Reactions and adverse events to the treatment
Efficacy of phage therapy
No recurrence of the infection
Tolerability of phage therapy
Reactions and adverse events to the intravenous and intra-articular administration
Changes in biomarkers (C-reactive protein)
Serum C-reactive protein (mg/L) as measured at baseline
Changes in biomarkers (erythrocyte sedimentation rate)
Serum erythrocyte sedimentation rate (mm/hr) as measured at baseline
Changes in biomarkers (interleukin-6)
Serum interleukin-6 (pg/mL) as measured at baseline
Changes in biomarkers (phage titres)
Phage particles present in a given volume of liquid (PFU/mL)
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Orthopaedic Innovation Centre
Lead sponsor
Cytophage Technologies Inc.
Collaborator
Ottawa Hospital Research Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
