Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621251
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2 Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Chronic Prosthetic Joint Infection of the Knee or Hip Without Exchange Arthroplasty
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:
None
Brief Summary:
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue thus making pathogens substantially more susceptible to established antibiotic treatment regimens This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR debridement antibiotics and implant retention procedure for chronic prosthetic joint infections of the knee and hip specifically eliminating the need for the standard of care 2-stage exchange surgery so that the original prosthesis can be retained
Detailed Description:
Approximately 75 of all clinically significant human infections are estimated to be biofilm-related Prosthetic joint infections are a classical example of difficult to eradicate infections associated with biofilm Most Prosthetic Joint Infection PJI cases are caused by staphylococcal species 70 with an increasing number being antibiotic-resistant MRSA In the US two-stage revision is the standard of care for replacement of an infected prosthetic joint and is associated with substantial costs and prolonged immobility TRL1068 is a fully human antibody that has been shown in pre-clinical studies and in the first-in-human Phase 1 study TRL1068-101 to disrupt biofilm TRL1068 targets a highly conserved epitope on the DNABII family of bacterial DNA binding proteins that includes histone-like HU and integration host factor IHF proteins of clinically relevant Gram-positive and Gram-negative bacteria The DNABII epitope bound by TRL1068 has no homologs in the human proteome
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