MedTrace Logo

Use of Phage Therapy for Treatment of a Periprosthetic Joint Infection

NCT06827041 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-02-14

No results posted yet for this study

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

Conditions

  • Periprosthetic Joint Infection

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Cytophage Technologies Inc.

    collaborator UNKNOWN

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Marisa A Azad, MD PhD · Ottawa Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06827041 on ClinicalTrials.gov