Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT04787250
Status:
WITHDRAWN
Last Update Posted:
2022-04-04
First Post:
2021-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
Sponsor:
Adaptive Phage Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changes to protocol design
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
Detailed Description:
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.
This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: