Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery

NCT07180615 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025-01074
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this clinical trial is to find out if a gut cleaning using Rifaximin works as well as the usual treatment with Neomycin and Metronidazole to prevent infections after colon surgery. The study includes adult patients who will have colon surgery. The main question it aims to answer are:

• Does the Rifaximin treatment prevent surgical site infections as well as the Neomycin/Metronidazole treatment? Other things the study will look at:
• How often infections happen, stratified on how deep they are, the type of surgery the patients got, or if bowel cleaning was done before surgery.
• How many people will die after surgery
• How long people stay in hospital Participants will:
• Take either Rifaximin or Neomycin/Metronidazole one day before surgery to clean their gut
• Keep a diary until the surgery to record medication intake and any side effects
• Be contacted by phone 30 days after surgery to ask about their condition and any side effects,

Conditions

Surgical Site Infection; Colon Surgery; Surgical Site Infections

Keywords

SSI; surgical site infection; Metronidazol; flagyl; neomycine; rifaximin; colon surgery; antibiotics; preoperative decolonisation

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection (deep and/or organ space)

  Assessment of surgical site infection (SSI) is following Swissnoso standard procedures and comprises a routine surveillance for means of quality control in all participating centers, irrespective of participation in this study. In brief, IP nurses supervised by infectious diseases specialists or other physicians without hierarchical link with the departments of surgery are in charge of the surveillance in each participating hospital. Patients are followed-up by IP nurses during their hospital stay and post-discharge for 30 days. Any suspicion of SSI or unclear situation is presented to the supervising physician for decision about the diagnosis of SSI. The post-discharge follow-up is done performed by IP nurses through standardized phone interviews with the patients. CDC critiera will be applied to determine the presence of SSI.

  The occurrence of surgical site infections is evaluated at two time points: 1. At time of dismissal from the hospital (up to d30) 2. If the patients is discharged: Via post-discharge surveillance at 30 days after surgery

Secondary Outcomes (2)

• Mortality

  up to 30 days after surgery

• Length of stay

  up to 30 days after surgery

Study Arms (2)

Metronidazol/Neomycin

ACTIVE COMPARATOR

Currently the most frequently used antibiotics for gut decolonisation prior to colon surgery (Standard of care)

Drug: Metronidazole; Drug: Neomycin Sulfate

Rifaximin

EXPERIMENTAL

Antibiotic with poorly systemic resorption after oral administration, under investigation as an agent for gut decolonization before colon surgery

Drug: Rifaximin (Xifaxan)

Interventions

Rifaximin (Xifaxan) DRUG

Preoperative gut decolonization protocol based on oral Rifaximin 2x550mg 10 am and 10 pm on the day preceding the surgery

Rifaximin

Metronidazole DRUG

Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery

Metronidazol/Neomycin

Neomycin Sulfate DRUG

Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery

Metronidazol/Neomycin

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥ 18 years
• undergoind planned colon surgery
• colon surgery will be included in Swissnoso SSI surveillance
• informed consent

You may not qualify if:

• contraindications and/or intolerance to one of the study compounds
• patients with underlying active infection (wound contamination class IV) at the timepoint of incision
• pregnant women
• unable to follow study protocol

Sponsors & Collaborators

• Universität Luzern: lead

Study Sites (4)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6006, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Rifaximin; Metronidazole; Neomycin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Rami Sommerstein, Prof. Dr. Med.

CONTACT

+41 41 208 32 54; rami.sommerstein@unilu.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Med.

Model Details: The intervention will be conducted as an open-label randomized multicenter trial. The patients at the participating study sites will be individually randomized using a computer-generated randomization prior to surgery. It is an open-label trial, meaning that patients and heathcare providers are aware of the assigned treatment.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 18, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)