Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456424
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-29
Brief Title:
Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHAGE-2024-01
Brief Summary:
This is a single-patient phase III 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
Detailed Description:
This study is a single-patient phase III 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 patients 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 patients 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
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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Dossier ID HC6-024-c283712 | OTHER | Health Canada | None |
| Control 286405 | OTHER | None | None |