Phage Therapy for the Treatment of a Chronic Enterococcus Faecium Periprosthetic Joint Infection

NCT06942624 | Not Yet Recruiting Phase 1

• 1 other identifier: OIC-Phage-2025-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periprosthetic Joint Infection

Outcome Measures

Primary Outcomes (3)

• Safety of phage therapy

  Reactions and adverse events to the treatment

  Day 0 to 1 year from treatment

• Efficacy of phage therapy

  No recurrence of the infection

  1 Year

• Tolerability of phage therapy

  Reactions and adverse events to the intravenous and intra-articular administration

  Day 0 to Day 13 of treatment

Secondary Outcomes (4)

• Changes in biomarkers (C-reactive protein)

  Day 0 to 1 year from treatment

• Changes in biomarkers (erythrocyte sedimentation rate)

  Day 0 to 1 year from treatment

• Changes in biomarkers (interleukin-6)

  Day 0 to 1 year from treatment

• Changes in biomarkers (phage titres)

  Day 0 to Day 13 of treatment

Study Arms (1)

Phage Therapy

EXPERIMENTAL

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

Interventions

Phage Therapy BIOLOGICAL

Our phage is an investigational treatment for bacterial infections. Our lytic phage preparation was provided by Cytophage Technologies (CIP-200).

Phage Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Chronic prosthetic joint infection
• History of multiple surgical and medication managements with no success

You may not qualify if:

• below 18 years of age

Sponsors & Collaborators

• Orthopaedic Innovation Centre: lead
• Cytophage Technologies Inc.: collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

MeSH Terms

Interventions

Phage Therapy

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• David Hedden, MD

  Concordia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Tran

CONTACT

204-926-1231; stran@orthoinno.com

Christiaan Righolt, PhD

CONTACT

204-926-1224; crigholt@orthoinno.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Lytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: * intravenously twice daily, and concomitantly, * 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

CA (1)