NCT02618720

Brief Summary

To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day before surgery) and intravenous cephalosporin (before surgical incision) with that of intravenous cephalosporin alone (standard of care) in combination with oral placebo on the incidence of SSI within 30 days after elective colorectal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
920

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 25, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

November 5, 2015

Last Update Submit

April 16, 2026

Conditions

Elective Colorectal Surgery

Keywords

Antimicrobial prophylaxisColorectal surgerySurgical Site InfectionPostoperative morbidity

Outcome Measures

Primary Outcomes (1)

  • occurrence of any SSI within 30 days after surgery.

    The primary end point of the trial is the occurrence of any SSI within 30 days after surgery. SSI will be classified as superficial, deep and/or organ-space infection according to validated and well-defined criteria developed by the Centers for Disease Control and Prevention (CDC).

    30 days after surgery

Secondary Outcomes (20)

  • Incidence of individual types of SSI according to the group of treatment

    30 days after surgery

  • Number of postoperative complications

    30 days after surgery

  • Number of surgical complications: anastomotic leakage and the need for abdominal reoperation and/or radiological intervention

    30 days after surgery

  • Duration of hospital stay

    30 days after surgery

  • All-cause mortality

    30 days after surgery

  • +15 more secondary outcomes

Study Arms (2)

ornidazole

EXPERIMENTAL

oral antibiotic prophylaxis using ornidazole, which has a spectrum of activity extended to most anaerobic bacteria and whose pharmacokinetic profile allows a single administration the day before surgery, in addition to intravenous antibiotic prophylaxis could be more effective than intravenous antibiotic prophylaxis alone using cephalosporin in reducing the incidence of SSI after elective colorectal surgery. Given the number of patients operated of colorectal surgery each year, the study is of significant clinical importance

Drug: ornidazole

placebo

PLACEBO COMPARATOR

oral antibiotic prophylaxis using ornidazole, which has a spectrum of activity extended to most anaerobic bacteria and whose pharmacokinetic profile allows a single administration the day before surgery, in addition to intravenous antibiotic prophylaxis could be more effective than intravenous antibiotic prophylaxis alone using cephalosporin in reducing the incidence of SSI after elective colorectal surgery. Given the number of patients operated of colorectal surgery each year, the study is of significant clinical importance

Drug: Placebo

Interventions

ornidazoleDRUG
ornidazole
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Laparoscopic or non-laparoscopic elective colorectal surgery

You may not qualify if:

  • Non elective colorectal surgery (emergent surgery and/or reintervention or revision of a previous colorectal procedure)
  • Significant concomitant surgical procedure (e.g., liver resection for metastasis)
  • Bacterial infection at the time of surgery or antimicrobial therapy up to 2 weeks before surgery
  • Inflammatory bowel disease
  • Severe obesity (defined as a BMI \>35 kg/m2)
  • Known history of hypersensitivity to β-lactams and imidazoles
  • Preoperative severe impairment in renal function (creatinine clearance (MDRD) \< 30 ml/min)
  • Patients with known colonization with multidrug-resistant digestive bacteria, especially multidrug-resistant gram-negative bacteria (requiring specific infection control measures)
  • Allergy to lactose, galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (rare metabolic disease)
  • Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive- Refusal to participate or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (3)

  • Futier E, Jaber S, Garot M, Vignaud M, Panis Y, Slim K, Lucet JC, Lebuffe G, Ouattara A, El Amine Y, Couderc P, Dupre A, De Jong A, Lasocki S, Leone M, Pottecher J, Pereira B, Paugam-Burtz C; COMBINE study group. Effect of oral antimicrobial prophylaxis on surgical site infection after elective colorectal surgery: multicentre, randomised, double blind, placebo controlled trial. BMJ. 2022 Nov 3;379:e071476. doi: 10.1136/bmj-2022-071476.

    PMID: 36328372RESULT

  • Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

    PMID: 36748942DERIVED

  • Vignaud M, Paugam-Burtz C, Garot M, Jaber S, Slim K, Panis Y, Lucet JC, Bourdier J, Morand D, Pereira B, Futier E; COMBINE trial management committee. Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) for the prevention of surgical site infection in elective colorectal surgery: study protocol for a multicentre, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Apr 12;8(4):e020254. doi: 10.1136/bmjopen-2017-020254.

    PMID: 29654027DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ornidazole

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

December 1, 2015

Study Start

May 25, 2016

Primary Completion

November 26, 2019

Study Completion

June 30, 2020

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)