Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636669
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Peri-operative Adjunctive Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Prosthetic joint infection PJI is one of the most devastating complications following total joint arthroplasty TJA of the hip and knee Standard of care SOC treatment includes surgery and antimicrobials Morbidity and mortality remain high despite contemporary treatments The human body is colonized by billions of organisms collectively the microbiome which is central to healthy immune function Microbiome disruption dysbiosis can impair the immune response to infection
Despite recent evidence that suggests dysbiosis may be implicated in PJI the role of probiotics in the treatment of PJI is unknown Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI A multi-centered randomized controlled trial RCT at two academic tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI Controls will receive SOC study patients will receive a probiotic started shortly after the initiation of and for the duration of their antibiotic therapy 7 days in addition to SOC Primary outcome is re-operation for recurrent infection within 1 year
Despite recent evidence that suggests dysbiosis may be implicated in PJI the role of probiotics in the treatment of PJI is unknown Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI A multi-centered randomized controlled trial RCT at two academic tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI Controls will receive SOC study patients will receive a probiotic started shortly after the initiation of and for the duration of their antibiotic therapy 7 days in addition to SOC Primary outcome is re-operation for recurrent infection within 1 year
Detailed Description:
The primary and secondary aims for this RCT are
Primary Aim 11 To determine the impact of administration of probiotics administered for 6 weeks after the index surgical treatment for PJI on reinfection rates deep infection within 1 year following revision TJA for PJI in each of the treatment arms probiotics and standard of care
Secondary Aims 21 To evaluate the incidence of superficial infections including wound drainage cellulitis or infections superficial to the deep fascia within 1 year following revision TJA for PJI in each of the treatment arms probiotics and standard of care
22 To evaluate the safety of use of probiotics in this population and to monitor the incidence of adverse events in patients administered probiotics versus standard of care in patients undergoing treatment for PJI
23 To evaluate the 1-year mortality rate in patients undergoing revision TJA for PJI in each of treatment arms probiotics and standard of care
24 To evaluate the rate of wound healing and dehiscence in patients undergoing revision TJA for PJI in each of treatment arms probiotics and standard of care
25 To evaluate the need for chronic antibiotic suppression for the treatment of PJI at final follow-up of one year following revision TJA for PJI in each of the treatment arms probiotics and standard of care
26 To evaluate the rate of infection with Clostridium difficile within 90 days of finishing antibiotic therapy in each of the treatment arms probiotics and standard of care The risk of developing C difficile infection is present for 90 days following cessation of antibiotic treatment
Primary Aim 11 To determine the impact of administration of probiotics administered for 6 weeks after the index surgical treatment for PJI on reinfection rates deep infection within 1 year following revision TJA for PJI in each of the treatment arms probiotics and standard of care
Secondary Aims 21 To evaluate the incidence of superficial infections including wound drainage cellulitis or infections superficial to the deep fascia within 1 year following revision TJA for PJI in each of the treatment arms probiotics and standard of care
22 To evaluate the safety of use of probiotics in this population and to monitor the incidence of adverse events in patients administered probiotics versus standard of care in patients undergoing treatment for PJI
23 To evaluate the 1-year mortality rate in patients undergoing revision TJA for PJI in each of treatment arms probiotics and standard of care
24 To evaluate the rate of wound healing and dehiscence in patients undergoing revision TJA for PJI in each of treatment arms probiotics and standard of care
25 To evaluate the need for chronic antibiotic suppression for the treatment of PJI at final follow-up of one year following revision TJA for PJI in each of the treatment arms probiotics and standard of care
26 To evaluate the rate of infection with Clostridium difficile within 90 days of finishing antibiotic therapy in each of the treatment arms probiotics and standard of care The risk of developing C difficile infection is present for 90 days following cessation of antibiotic treatment
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