Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection

Phase 1

Not yet recruiting

• Conditions: Prosthetic Joint Infections of Hip
• Interventions: Biological: phage therapy

• Registration Number: NCT06814756
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Study Start: 2025-02-24
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Arm	phage therapy	Bacteriophage drug product

Primary Outcome Measures

Name	Time	Method
Clinical response to phage therapy as determined by participant's absence of physical symptoms	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events	29 days	The safety outcome focuses on monitoring and documenting any adverse events (both serious and not) or reactions associated with bacteriophage therapy. Key safety measures include observing for immediate allergic reactions during the first dose, conducting regular clinical assessments, and performing routine bloodwork to detect any potential organ damage or unexpected side effects.