Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection

NCT06456424 | Active Not Recruiting Phase 1

• 3 other identifiers: REB23-1733Control #: 286405Dossier ID: HC6-024-c283712
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to his quality of life. The treatment involves a one time, intra-operative injection of bacteriophages into the joint and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.

Conditions

Prosthetic Joint Infections of Hip; Staphylococcus Aureus Infection

Keywords

Single patient; Bacteriophage; Phage

Outcome Measures

Primary Outcomes (1)

• Clinical response

  Resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever. This will be determined by a questionnaire and monthly assessments by a Infectious Disease physician.

  1 year

Secondary Outcomes (3)

• Safety of phage therapy

  29 days

• Microbiologic response

  1 year

• Biochemical response

  1 year

Study Arms (1)

Open Label Arm

EXPERIMENTAL

Bacteriophage cocktail

Biological: Phage therapy

Interventions

Phage therapy BIOLOGICAL

Bacteriophage cocktail consisting of phages BP13 and J1P3

Open Label Arm

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of active chronic prosthetic joint infection
• Causative bacteria is susceptible to bacteriophage therapy in vitro
• History of multiple failed antibiotic and surgical interventions

You may not qualify if:

• Stage 5 chronic kidney disease
• Cirrhosis
• A known allergy to phage products
• Fever
• Involvement in another clinical trial
• Pregnancy

Sponsors & Collaborators

• University of Calgary: lead
• University of Toronto: collaborator
• Precisio Biotix Therapeutics, Inc.: collaborator

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Phage Therapy

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

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: Single patient

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 13, 2024
• Study Start: November 20, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)