Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT07180615
Status:
None
Last Update Posted:
2025-09-18 00:00:00
First Post:
2025-08-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery
Sponsor:
None
Organization:
Study Overview
Official Title:
Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial
Status:
None
Status Verified Date:
2025-09
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:
NeoRiDe
Brief Summary:
Surgical site infections (SSIs) are the most frequent infections in patients undergoing colon surgery, leading to considerable morbidity, mortality and increased healthcare costs. As SSIs are often caused by endogenous gut flora, oral antibiotic gut decolonisation prior to colon surgeries is standard practice. However the optimal antibiotic regimen remains unclear.
This phase IV, multicenter, open-label randomized controlled trial aims to evaluate whether a rifaximin-based protocol is non-inferior to the current standard regimen of neomycin and metronidazole in preventing SSIs.
Rifaximin is a semi-synthetic derivate with poor systemic absorption, allowing for local gut action and a broad antibacterial spectrum covering gram-positiv, - negativ, aerobic aswell as anaerobic bacteria. It is approved in Switzerland for hepatic encephalopathy and has a favorable safety profile with mostly mild gastrointestinal side effects. Neomycin is FDA-approved for preoperative gut decolonisation. Common side effects include nausea, vomiting and diarrhea.
The study will include about 458 patients undergoing planned colon surgery at five swiss hospitals. Patients will be randomized in 1:1 ratio to receive either rifaximin 2x550mg per day or Neomycin 2x500mg plus Metronidazol 2x500mg per day, administeres orally at 10:00 AM and 10:00 PM on the day before surgery. Mechanical bowel preparation, when applied, is scheduled between 4:00 PM and 08:00 PM on the same day. The primary outcome is the incidence of SSI. Secondary outcomes include mortality and length of hospital stay.
Ramdomization is computer-generated. Blinding is limited to the responsible statisticians. Clinicians and patients are aware of the assigned treatment. Safety assessments focus on known side effects as documentes by reculatory agencies.
The study adresses a clinically important gap in evidence for the best antibiotic regimen for preoperative gut decolonisation.
This phase IV, multicenter, open-label randomized controlled trial aims to evaluate whether a rifaximin-based protocol is non-inferior to the current standard regimen of neomycin and metronidazole in preventing SSIs.
Rifaximin is a semi-synthetic derivate with poor systemic absorption, allowing for local gut action and a broad antibacterial spectrum covering gram-positiv, - negativ, aerobic aswell as anaerobic bacteria. It is approved in Switzerland for hepatic encephalopathy and has a favorable safety profile with mostly mild gastrointestinal side effects. Neomycin is FDA-approved for preoperative gut decolonisation. Common side effects include nausea, vomiting and diarrhea.
The study will include about 458 patients undergoing planned colon surgery at five swiss hospitals. Patients will be randomized in 1:1 ratio to receive either rifaximin 2x550mg per day or Neomycin 2x500mg plus Metronidazol 2x500mg per day, administeres orally at 10:00 AM and 10:00 PM on the day before surgery. Mechanical bowel preparation, when applied, is scheduled between 4:00 PM and 08:00 PM on the same day. The primary outcome is the incidence of SSI. Secondary outcomes include mortality and length of hospital stay.
Ramdomization is computer-generated. Blinding is limited to the responsible statisticians. Clinicians and patients are aware of the assigned treatment. Safety assessments focus on known side effects as documentes by reculatory agencies.
The study adresses a clinically important gap in evidence for the best antibiotic regimen for preoperative gut decolonisation.
Detailed Description:
None
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?: