Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06456424 |
| Other study ID # |
REB23-1733 |
| Secondary ID |
Control #: 28640 |
| Status |
Not yet recruiting |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Calgary |
| Contact |
Stephen D Vaughan, MD |
| Phone |
403-956-2403 |
| Email |
stephen.vaughan[@]albertahealthservices.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
