Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection

NCT ID: NCT06814756

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Prosthetic Joint Infections of Hip

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single patient
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Arm

Bacteriophage drug product

Group Type EXPERIMENTAL

phage therapy

Intervention Type BIOLOGICAL

Single anti-Morganella morganii bacteriophage drug product

Interventions

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phage therapy

Single anti-Morganella morganii bacteriophage drug product

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Qeen Biotechnologies

INDUSTRY

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Foothills Medical Centre, University of Calgary

Calgary, , Canada

Site Status

Countries

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Canada

Other Identifiers

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REB25-0157

Identifier Type: -

Identifier Source: org_study_id

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