Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection

NCT06814756 | Active Not Recruiting Phase 1

• 1 other identifier: REB25-0157
• 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 Morganella morganii 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

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 symptoms

  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 (1)

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

  29 days

Study Arms (1)

Open Label Arm

EXPERIMENTAL

Bacteriophage drug product

Biological: phage therapy

Interventions

phage therapy BIOLOGICAL

Single anti-Morganella morganii bacteriophage drug product

Open Label Arm

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

MeSH Terms

Interventions

Phage Therapy

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: January 22, 2025
• First Posted: February 7, 2025
• Study Start: March 26, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)