Bacteriophage Therapy for Staphylococcus Lugdunensis Prosthetic Joint Infection

NCT07461337 | Not Yet Recruiting Phase 1

• 1 other identifier: REB26-0079
• 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 drug product to treat and prevent the recurrence of a Staphylococcus lugdunensis prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. The treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area 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; Bacteriophage Therapy

Keywords

Bacteriophage; Periprosthetic joint infection; Phage therapy

Outcome Measures

Primary Outcomes (1)

• Clinical response to phage therapy as determined by participant's absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever.

  Resolution of the infection, indicated by the absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever. The infection will be considered to be resolved if these physical clinical symptoms are absent.

  1 year

Secondary Outcomes (1)

• Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events

  29 days

Study Arms (1)

Bacteriophage drug product

EXPERIMENTAL

Five phage anti-Staphylococcus aureus bacteriophage cocktail

Biological: Five phage anti-Staphylococcus aureus bacteriophage cocktail

Interventions

Five phage anti-Staphylococcus aureus bacteriophage cocktail BIOLOGICAL

Five phage anti-Staphylococcus aureus bacteriophage cocktail for targeted treatment of a Staphylococcus lugdunensis infection.

Bacteriophage drug product

Eligibility Criteria

• Sex: female
• 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
• Qeen Biotechnologies: collaborator

Study Sites (1)

Foothills Medical Centre, University of Calgary

Calgary, Canada

Location

Central Study Contacts

James N Powell, MD

CONTACT

403-536-3725; jamesn.powell@albertahealthservices.ca

Teresa Nguyen

CONTACT

403-536-3725

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: February 26, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)