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Active, Not Recruiting

NCT Number: NCT06456424

Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection

This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to his quality of life. The treatment involves a one time, intra-operative injection of bacteriophages into the joint 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prosthetic Joint Infections of Hip Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Staphylococcal Infections Staphylococcus Aureus Infection

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

About this study

This study is a single-patient, phase I/II clinical trial that addresses a challenging case of a recurrent methicillin-sensitive Staphylococcus aureus (MSSA) infection in a prosthetic hip joint despite extensive antibiotic treatments and multiple surgeries.

Given the failure of conventional treatments and the high risk associated with major surgical interventions, this study explores the use of bacteriophage therapy as an innovative alternative. Bacteriophages, viruses that specifically infect and lyse bacterial cells, offer a patient-specific, targeted approach to combating bacterial infections within biofilms. Our study will use a bacteriophage cocktail containing phages BP13 and J1P3, both of which have demonstrated in-vitro activity against the patient's strain of S. aureus.

The treatment protocol involves the administration of phages intra-articularly on day 1 and intravenously twice daily on days 1-14. This dual approach aims to enhance the efficacy of the phage therapy by ensuring both systemic and localized delivery of the phages to the infected site.

The primary outcome will be the resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever, as well as the normalization of inflammatory markers over a 12-month period following the phage therapy.

Throughout the study, the patient's safety and response to the treatment will be rigorously monitored through regular physical examinations, blood tests, and if needed, imaging studies. The initial dose of the phage cocktail will be administered in a hospital setting to monitor for any immediate adverse reactions Follow-up assessments will continue for a year to ensure long-term efficacy and safety.

The goal of this study is to demonstrate the potential of bacteriophage therapy as a viable treatment option for prosthetic joint infections, particularly those resistant to standard treatments. Success in this case could pave the way for broader applications of phage therapy in managing complex bacterial infections, offering a new avenue for treatment where traditional methods have failed.

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

Phage therapy

Biological

Bacteriophage cocktail consisting of phages BP13 and J1P3

Primary outcomes

  1. Clinical response

    Time frame: 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 outcomes

  1. Safety of phage therapy

    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 blood tests (complete blood counts, lymphocyte subsets, c-reactive protein, liver function tests, serum electrolytes and serum creatinine) to detect any potential organ damage or unexpected side effects.

  2. Microbiologic response

    Time frame: 1 year

    Bacterial cultures from the infected joint will be sent on an as-needed basis should the patient develop another draining fistula or require a repeat surgical incision and drainage. If there is no need to send bacterial cultures, or if bacteria other than Staphylococcus aureus are isolated, then this would be a good microbiologic response.

  3. Biochemical response

    Time frame: 1 year

    To monitor for subclinical infection the patient will have serum inflammatory markers (white blood cell count and c-reactive protein) sent on days 0, 2, 4, 8, 11, 15, 29, and then every 30 days afterwards. Should both inflammatory markers decrease to be within the normal limits this would be a good biochemical response.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Precisio Biotix Therapeutics, Inc.
  • University of Toronto

Registry information

Acronym: PHAGE-2024-01

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
Jun 11, 2025

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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