<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03042091</url>
  </required_header>
  <id_info>
    <org_study_id>16D.204</org_study_id>
    <nct_id>NCT03042091</nct_id>
  </id_info>
  <brief_title>Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery</brief_title>
  <official_title>Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with&#xD;
      or without polyethylene glycol work in reducing infection in patients undergoing elective&#xD;
      colorectal surgery. Polyethylene glycol, may draw water from the body into the colon,&#xD;
      flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole&#xD;
      hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to&#xD;
      give preoperative neomycin and metronidazole hydrochloride with or without polyethylene&#xD;
      glycol in reducing surgical site infection after colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate the difference in rates of surgical site infection following elective&#xD;
      colorectal resections in patients given a preoperative mechanical bowel prep with oral&#xD;
      antibiotics as compared to preoperative oral antibiotics alone.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine rates of post-operative clostridium difficile infection, adynamic ileus,&#xD;
      cardiopulmonary complications, urinary tract infection, length of stay and mortality in&#xD;
      patients given preoperative oral antibiotics with a mechanical bowel prep versus preoperative&#xD;
      antibiotics alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak</measure>
    <time_frame>Up to 30 days post operation</time_frame>
    <description>The difference in incidence of SSI (antibiotics [ABX] - ABX + prep) will be calculated with an upper 95% confidence bound. Exploratory analysis will consider stratum specific estimates of differences in subgroups defined by BMI and diabetes status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of post-operative clostridium difficile infection</measure>
    <time_frame>Up to 30 days post operation</time_frame>
    <description>The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adynamic ileus</measure>
    <time_frame>Up to 30 days post operation</time_frame>
    <description>The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cardiopulmonary complications</measure>
    <time_frame>Up to 30 days post operation</time_frame>
    <description>The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of urinary tract infection</measure>
    <time_frame>Up to 30 days post operation</time_frame>
    <description>The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to 30 days post operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mortality</measure>
    <time_frame>Up to 30 days post operation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Diverticulitis</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Arm I (mechanical bowel prep, oral antibiotics)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (oral antibiotics)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyethylene Glycol</intervention_name>
    <description>Given orally</description>
    <arm_group_label>Arm I (mechanical bowel prep, oral antibiotics)</arm_group_label>
    <other_name>25322-68-3</other_name>
    <other_name>57859</other_name>
    <other_name>Ethanol</other_name>
    <other_name>Glycol</other_name>
    <other_name>Polyethylene Glycol 400</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neomycin</intervention_name>
    <description>Given orally</description>
    <arm_group_label>Arm I (mechanical bowel prep, oral antibiotics)</arm_group_label>
    <arm_group_label>Arm II (oral antibiotics)</arm_group_label>
    <other_name>1404-04-2</other_name>
    <other_name>Neomycin Complex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole Hydrochloride</intervention_name>
    <description>Given orally</description>
    <arm_group_label>Arm I (mechanical bowel prep, oral antibiotics)</arm_group_label>
    <arm_group_label>Arm II (oral antibiotics)</arm_group_label>
    <other_name>69198-10-3</other_name>
    <other_name>Flagyl</other_name>
    <other_name>Metro I.V.</other_name>
    <other_name>Satric</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Therapeutic Conventional Surgery</intervention_name>
    <description>Undergo colorectal resection</description>
    <arm_group_label>Arm I (mechanical bowel prep, oral antibiotics)</arm_group_label>
    <arm_group_label>Arm II (oral antibiotics)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing ileocolic resections, partial and total colectomies, and rectal&#xD;
             resections for neoplasm, inflammatory bowel disease, or diverticulitis&#xD;
&#xD;
          -  Subjects with the mental capacity to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing emergent colorectal resections&#xD;
&#xD;
          -  Patients who are decisionally-impaired and lack the mental capacity to give informed&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Phillips, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamin Phillips, MD</last_name>
    <phone>(215) 551-0360</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Phillips, MD</last_name>
      <phone>215-551-0360</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Diverticulitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Neomycin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03042091
org study id: 16D.204
nct id: NCT03042091
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with
      or without polyethylene glycol work in reducing infection in patients undergoing elective
      colorectal surgery. Polyethylene glycol, may draw water from the body into the colon,
      flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole
      hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to
      give preoperative neomycin and metronidazole hydrochloride with or without polyethylene
      glycol in reducing surgical site infection after colorectal surgery.
PRIMARY OBJECTIVES:

      I. To estimate the difference in rates of surgical site infection following elective
      colorectal resections in patients given a preoperative mechanical bowel prep with oral
      antibiotics as compared to preoperative oral antibiotics alone.

      SECONDARY OBJECTIVES:

      I. To determine rates of post-operative clostridium difficile infection, adynamic ileus,
      cardiopulmonary complications, urinary tract infection, length of stay and mortality in
      patients given preoperative oral antibiotics with a mechanical bowel prep versus preoperative
      antibiotics alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
time frame: Up to 30 days post operation
description: The difference in incidence of SSI (antibiotics [ABX] - ABX + prep) will be calculated with an upper 95% confidence bound. Exploratory analysis will consider stratum specific estimates of differences in subgroups defined by BMI and diabetes status.
measure: Incidence of post-operative clostridium difficile infection
time frame: Up to 30 days post operation
description: The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
measure: Incidence of adynamic ileus
time frame: Up to 30 days post operation
description: The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound.
measure: Incidence of cardiopulmonary complications
time frame: Up to 30 days post operation
description: The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
measure: Incidence of urinary tract infection
time frame: Up to 30 days post operation
description: The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
measure: Length of hospital stay
time frame: Up to 30 days post operation
measure: Incidence of mortality
time frame: Up to 30 days post operation
arm group label: Arm I (mechanical bowel prep, oral antibiotics)
arm group type: Active Comparator
description: Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
arm group label: Arm II (oral antibiotics)
arm group type: Experimental
description: Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
intervention type: Drug
intervention name: Polyethylene Glycol
description: Given orally
arm group label: Arm I (mechanical bowel prep, oral antibiotics)
other name: 25322-68-3
other name: 57859
other name: Ethanol
other name: Glycol
other name: Polyethylene Glycol 400
intervention type: Drug
intervention name: Neomycin
description: Given orally
arm group label: Arm I (mechanical bowel prep, oral antibiotics)
arm group label: Arm II (oral antibiotics)
other name: 1404-04-2
other name: Neomycin Complex
intervention type: Drug
intervention name: Metronidazole Hydrochloride
description: Given orally
arm group label: Arm I (mechanical bowel prep, oral antibiotics)
arm group label: Arm II (oral antibiotics)
other name: 69198-10-3
other name: Flagyl
other name: Metro I.V.
other name: Satric
intervention type: Procedure
intervention name: Therapeutic Conventional Surgery
description: Undergo colorectal resection
arm group label: Arm I (mechanical bowel prep, oral antibiotics)
arm group label: Arm II (oral antibiotics)
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Phillips, MD
role: Principal Investigator
affiliation: Thomas Jefferson University
last name: Benjamin Phillips, MD
phone: (215) 551-0360
facility: 
status: Recruiting
contact: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
mesh term: Colorectal Neoplasms
mesh term: Inflammatory Bowel Diseases
mesh term: Diverticulitis
mesh term: Metronidazole
mesh term: Ethanol
mesh term: Neomycin