Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605651
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Proof of Concept Multicenter Randomized Double-Blind Study to Assess the Safety and Efficacy of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated by DAIR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLORIA
Brief Summary:
Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections PJI primarily caused by Staphylococcus aureus and resistant to antibiotics Standard treatment involves DAIR surgery and antibiotics but theres a need for better solutions due to rising infections and antibiotic resistance Bacteriophage therapy which targets specific bacteria shows promise Phaxiam Therapeutics is studying the safety and efficacy of phage therapy in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR
Detailed Description:
Total joint replacement serves as valuable interventions in the management of chronic refractory pain when the other conservative treatments have not worked They play a vital role in alleviating discomfort and improving the quality of life of subjects battling with joint diseases However the joint replacements present the challenge of Prosthetic Joint Infection PJI PJI have serious complications and can lead to significant mortality morbidity and healthcare expenditure
The leading cause of PJI is gram-positive cocci specifically Staphylococcus aureus Bacterial biofilms mainly formed with Staphylococcus represent a significant challenge in the treatment of PJIs due to their resistance to antibiotic therapy Standard of Care SOC for these complex infections is characterized primarily by an initial surgery Debridment Antibiotics and Implant Retention DAIR and various regiments and combinations of antibiotics While the patterns of utilization vary between institutions and geography DAIR is considered low-invasive procedure characterized by the possibility of not explanting the prosthetic implant and resecting the bone The growing demand for joint arthroplasty and current PJI rates combined with antibacterial resistance clearly indicate an unmet medical need in treating biofilm-based PJIs
Bacteriophage therapy could potentially improve the treatment paradigm for PJIs Bacteriophages naturally occur with highly specific bacterial viruses that infiltrate bacterial cells disrupting their metabolism and causing bacterial lysis Initial in vivo studies of phage therapy for bone-related infections have shown promise
Phaxiam Therapeutics a biotechnology company specializing in the research and development of anti-infective therapies using bacteriophages has collections of phages against Escherichia coli Pseudomonas aeruginosa and Staphylococcus aureus These phages have shown promise in preliminary tests and studies
The objective of GLORIA study Is to assess the safety and efficacy of phage therapy versus placebo in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR
The leading cause of PJI is gram-positive cocci specifically Staphylococcus aureus Bacterial biofilms mainly formed with Staphylococcus represent a significant challenge in the treatment of PJIs due to their resistance to antibiotic therapy Standard of Care SOC for these complex infections is characterized primarily by an initial surgery Debridment Antibiotics and Implant Retention DAIR and various regiments and combinations of antibiotics While the patterns of utilization vary between institutions and geography DAIR is considered low-invasive procedure characterized by the possibility of not explanting the prosthetic implant and resecting the bone The growing demand for joint arthroplasty and current PJI rates combined with antibacterial resistance clearly indicate an unmet medical need in treating biofilm-based PJIs
Bacteriophage therapy could potentially improve the treatment paradigm for PJIs Bacteriophages naturally occur with highly specific bacterial viruses that infiltrate bacterial cells disrupting their metabolism and causing bacterial lysis Initial in vivo studies of phage therapy for bone-related infections have shown promise
Phaxiam Therapeutics a biotechnology company specializing in the research and development of anti-infective therapies using bacteriophages has collections of phages against Escherichia coli Pseudomonas aeruginosa and Staphylococcus aureus These phages have shown promise in preliminary tests and studies
The objective of GLORIA study Is to assess the safety and efficacy of phage therapy versus placebo in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None