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

April 17, 2025 updated by: Orthopaedic Innovation Centre

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Concordia Hospital
        • Contact:
        • Sub-Investigator:
          • David Hedden, MD FRCSC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • below 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phage Therapy
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of phage therapy
Time Frame: Day 0 to 1 year from treatment
Reactions and adverse events to the treatment
Day 0 to 1 year from treatment
Efficacy of phage therapy
Time Frame: 1 Year
No recurrence of the infection
1 Year
Tolerability of phage therapy
Time Frame: Day 0 to Day 13 of treatment
Reactions and adverse events to the intravenous and intra-articular administration
Day 0 to Day 13 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in biomarkers (C-reactive protein)
Time Frame: Day 0 to 1 year from treatment
Serum C-reactive protein (mg/L) as measured at baseline
Day 0 to 1 year from treatment
Changes in biomarkers (erythrocyte sedimentation rate)
Time Frame: Day 0 to 1 year from treatment
Serum erythrocyte sedimentation rate (mm/hr) as measured at baseline
Day 0 to 1 year from treatment
Changes in biomarkers (interleukin-6)
Time Frame: Day 0 to 1 year from treatment
Serum interleukin-6 (pg/mL) as measured at baseline
Day 0 to 1 year from treatment
Changes in biomarkers (phage titres)
Time Frame: Day 0 to Day 13 of treatment
Phage particles present in a given volume of liquid (PFU/mL)
Day 0 to Day 13 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopaedic Innovation Centre

Collaborators

Ottawa Hospital Research Institute
Cytophage Technologies Inc.

Investigators

  • Principal Investigator: David Hedden, MD, Concordia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OIC-Phage-2025-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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