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NCT Number: NCT07461337

Bacteriophage Therapy for Staphylococcus Lugdunensis Prosthetic Joint Infection

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.

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Key information

Conditions

Prosthetic Joint Infections of Hip Bacteriophage Therapy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Five phage anti-Staphylococcus aureus bacteriophage cocktail

Biological

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

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.

    Time frame: 1 year

    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.

Secondary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

James N Powell, MD

CONTACT

[email protected]

403-536-3725

Teresa Nguyen

CONTACT

403-536-3725

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Qeen Biotechnologies

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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