Surgical Site InfectionPhase 4NeoRiDeNCT07180615
Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery
A Phase 4 study testing Rifaximin (Xifaxan), Metronidazole and Neomycin Sulfate in people with Surgical Site Infection and Colon Surgery, run by Universität Luzern at 4 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Colon Surgery, Surgical Site Infections
- What is being tested?
- Rifaximin (Xifaxan), Metronidazole and Neomycin Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 1 Jun 2026to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥ 18 years
- undergoind planned colon surgery
- colon surgery will be included in Swissnoso SSI surveillance
- informed consent
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites
Kantonsspital Aarau
Aarau, 5001
Luzerner Kantonsspital
Lucerne, 6006
Kantonsspital St. Gallen
Sankt Gallen, 9007
Stadtspital Triemli
Zurich, 8063
About this study
Official title: Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial
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:
Read more
-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,
Read the detailed description
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.
- Being tested
- Rifaximin (Xifaxan), Metronidazole, Neomycin Sulfate
- Keywords
- SSI, surgical site infection, Metronidazol, flagyl, neomycine, rifaximin, colon surgery, antibiotics, preoperative decolonisation
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin (Xifaxan)Drug
Preoperative gut decolonization protocol based on oral Rifaximin 2x550mg 10 am and 10 pm on the day preceding the surgery
MetronidazoleDrug
Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
Neomycin SulfateDrug
Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
| Study group | Role | What they receive |
|---|---|---|
| Metronidazol/Neomycin | Active comparator | Currently the most frequently used antibiotics for gut decolonisation prior to colon surgery (Standard of care) Receives: 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 Receives: Drug: Rifaximin (Xifaxan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To investigate the occurance of death
Measured: up to 30 days after surgery
Length of stay
Time of hospitalization after surgery
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Luzern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Sommerstein, Universität Luzern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180615
- Sponsor's protocol ID
- 2025-01074
- Other IDs
- 2025
- Acronym
- NeoRiDe
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT07180615
- Acronym / sponsor ID
- NeoRiDe / 2025-01074
- Keywords
- SSI, surgical site infection, Metronidazol, flagyl, neomycine, rifaximin, colon surgery, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Universität LuzernUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Metronidazol/Neomycin | Active comparator | Drug: Metronidazole, Drug: Neomycin SulfateCurrently the most frequently used antibiotics for gut decolonisation prior to colon surgery (Standard of care) |
| Rifaximin | Experimental | Drug: Rifaximin (Xifaxan)Antibiotic with poorly systemic resorption after oral administration, under investigation as an agent for gut decolonization before colon surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥ 18 years
- undergoind planned colon surgery
- colon surgery will be included in Swissnoso SSI surveillance
- informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin (Xifaxan)Preoperative gut decolonization protocol based on oral Rifaximin 2x550mg 10 am and 10 pm on the day preceding the surgery | Drug | Rifaximin |
| MetronidazolePreoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery | Drug | Metronidazol/Neomycin |
| Neomycin SulfatePreoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery | Drug | Metronidazol/Neomycin |
Primary outcome
Surgical Site Infection (deep and/or organ space)
Time frame: 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
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.
2 secondary outcomes
Mortality
Time frame: up to 30 days after surgery
Length of stay
Time frame: up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin (Xifaxan), Metronidazole and Neomycin Sulfate in people with Surgical Site Infection and Colon Surgery, run by Universität Luzern at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rami Sommerstein, Prof. Dr. Med. (+41 41 208 32 54, rami.sommerstein@unilu.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (deep and/or organ space) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.