A Phase 1/2 interventional study of Phage Therapy in Periprosthetic Joint Infection, sponsored by Orthopaedic Innovation Centre. Not yet recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Orthopaedic Innovation Centre · Phase 1/2, Interventional, and Treatment
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.
This is a single-patient study, to assess a treatment option for a case of a recurrent methicillin-susceptible E. faecium infection in a prosthetic hip joint. The patient has repeatedly failed standard of care medical and surgical management.
Given the severity and chronicity of E. faecium infection and burden of infected hardware, the only option to achieve surgical source control would involve an aggressive, high risk surgical approach: a high amputation of the left leg to remove infected hardware and peri-implant bone and tissues. In the absence of any viable adjunctive antimicrobial therapy, this patient is at high risk of mortality and morbidity. It is therefore paramount that we explore alternative treatment modalities for the management of this infection, such as bacteriophage (phage) therapy.
The primary objective of this study is to investigate the preliminary efficacy, safety, and tolerability of systemic (intravenous) and intra-articular administration of a lytic phage (in our patient with chronic E. faecium PJI.
Secondary objectives will be documenting 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 as well as phage titres.
In this study, lytic phage prepared in injection-grade saline will be administered to the patient both intravenously and intraarticularly, twice a day for a duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.
The patient will remain in clinical follow-up for up to one year.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 1 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Orthopaedic Innovation Centre is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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This N-of-1 Phage therapy is designed for one patient who meet the following conditions
Exclusion Criteria:
Lytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: a) intravenously twice daily, and concomitantly, b) intra-articularly twice daily, for a total duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.
Biological: Phage Therapy
Our 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
Time frame: Day 0 to 1 year from treatment
Efficacy of phage therapy
No recurrence of the infection
Time frame: 1 Year
Tolerability of phage therapy
Reactions and adverse events to the intravenous and intra-articular administration
Time frame: Day 0 to Day 13 of treatment
Changes in biomarkers (C-reactive protein)
Serum C-reactive protein (mg/L) as measured at baseline
Time frame: Day 0 to 1 year from treatment
Changes in biomarkers (erythrocyte sedimentation rate)
Serum erythrocyte sedimentation rate (mm/hr) as measured at baseline
Time frame: Day 0 to 1 year from treatment
Changes in biomarkers (interleukin-6)
Serum interleukin-6 (pg/mL) as measured at baseline
Time frame: Day 0 to 1 year from treatment
Changes in biomarkers (phage titres)
Phage particles present in a given volume of liquid (PFU/mL)
Time frame: Day 0 to Day 13 of treatment
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Orthopaedic Innovation Centre