Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189885
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-19
Brief Title:
Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty A Prospective Randomized Double-Blinded Trial
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Preoperative Daptomycin Prophylaxis for Preventing Gram-Positive or Methicillin-Resistant Staphylococcus Aureus Infection in Two-Stage Exchange Arthroplasty A Prospective Randomized Double-Blinded Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
The gold standard for treating prosthetic joint infection PJI is two-stage exchange arthroplasty This includes the first stage of debridement and removal of the artificial joint and the second stage of reimplantation of the artificial joint Methicillin-resistant staphylococcus aureus MRSA infection is one of the factors leading to the failure of artificial joint infection treatment Before the second stage of the joint surgery the surgeon will prescribe prophylactic antibiotics based on previous bacterial cultures The usual preoperative antibiotic is a first-generation cephalosporin antibiotic If it is MRSA vancomycin will be given Increasingly literature reports link prosthetic joint infections to MRSA but no changes have been made to the routine recommendation for MRSA prophylactic antibiotic use
Daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones and its safety and tolerability have been confirmed Therefore it can effectively combat Gram-positive organisms including MRSA Daptomycin has many characteristics of an ideal prophylactic short infusion time low adverse events during administration and a range limited to Gram-positive organisms We aim to assess whether adding antibiotics that cover MRSA would reduce prosthetic joint infections and increase surgical success rates in addition to the standard recommended prophylactic antibiotics Thus this prospective randomized trial is designed to assess besides using the first-generation cephalosporin antibiotic the effects of adding an antibiotic with MRSA coverage Daptomycin vs Vancomycin
Daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones and its safety and tolerability have been confirmed Therefore it can effectively combat Gram-positive organisms including MRSA Daptomycin has many characteristics of an ideal prophylactic short infusion time low adverse events during administration and a range limited to Gram-positive organisms We aim to assess whether adding antibiotics that cover MRSA would reduce prosthetic joint infections and increase surgical success rates in addition to the standard recommended prophylactic antibiotics Thus this prospective randomized trial is designed to assess besides using the first-generation cephalosporin antibiotic the effects of adding an antibiotic with MRSA coverage Daptomycin vs Vancomycin
Detailed Description:
None
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