Use of Phage Therapy for Treatment of a Periprosthetic Joint Infection

NCT06827041 | Active Not Recruiting Phase 1

• 1 other identifier: 20231130
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety of phage therapy

  Reactions and adverse events to study treatment.

  From first day to 12 months from treatment

• Efficacy of phage therapy (clinical response)

  Wound healing and no recurrence of the infection as determined by the orthopedic infectious diseases physician during follow-up to 12 months from phage treatment.

  1 year

Secondary Outcomes (3)

• Response of laboratory markers (C-reactive protein) of inflammation to phage treatment

  1 year

• Response of laboratory markers (erythrocyte sedimentation rate) of inflammation to phage treatment

  1 year

• Response of laboratory markers (peripheral blood neutrophil count) of inflammation to phage treatment

  1 year

Study Arms (1)

Phage therapy

EXPERIMENTAL

Lytic monophage prepared in injection-grade saline 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 (Cytophage Technologies)

Interventions

Phage (Cytophage Technologies) BIOLOGICAL

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.

Phage therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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.
• severe chronic periprosthetic joint infection due to a multidrug resistant strain of S. epidermidis in which surgical source control with complete removal of implants cannot be safely achieved
• have received multiple surgical revisions with complex reconstructions and adjunctive flap coverage procedures and prolonged courses of antibiotic therapy and suffered multiple, severe antibiotic allergic reactions during initial treatment course which has lead to the use of any viable suppressive therapy impossible
• complex burden of hardware
• poor bone quality and hip instability with high associated morbidity and mortality due to the S. epidermidis infection

You may not qualify if:

• \- below age 18 years

Sponsors & Collaborators

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

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Study Officials

• Marisa A Azad, MD PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Lytic monophage prepared in injection-grade saline will be given via two routes: 1. intravenously twice daily, and concomitantly, 2. intraarticularly 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 3, 2024
• First Posted: February 14, 2025
• Study Start: February 22, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 months from study treatment
• Access Criteria: Any desired information may be requested directly of the principal investigator

Locations

CA (1)