<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/NCT03289351</url>
  </required_header>
  <id_info>
    <org_study_id>17-011</org_study_id>
    <nct_id>NCT03289351</nct_id>
  </id_info>
  <brief_title>Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis</brief_title>
  <official_title>Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Phoenix Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Phoenix Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      After appendix has been removed for perforated appendicitis, patients will receive&#xD;
      postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3&#xD;
      -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug&#xD;
      therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a&#xD;
      single-drug therapy, there are additional benefits of simplicity, compliance, and lower&#xD;
      infectious complications. Currently surgeons are already using both 2-drug regimen&#xD;
      (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA&#xD;
      approved and regulated antibiotics for intra-abdominal infection. There is a clear need to&#xD;
      compare outcomes between these two options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The diagnosis of perforated appendicitis will be documented intraoperatively with photos of&#xD;
      extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to&#xD;
      121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded&#xD;
      sequence model. 30 day postoperative follow up visit or calls will be made to assess and&#xD;
      collect infectious complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Anticipated">September 8, 2023</completion_date>
  <primary_completion_date type="Actual">November 17, 2021</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Intra-abdominal Abscess</measure>
    <time_frame>30 days</time_frame>
    <description>Intra-abdominal abscess documented by ultrasound or computerized tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Surgical Site Infection</measure>
    <time_frame>30 days</time_frame>
    <description>surgical site infections including superficial port site infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Readmission</measure>
    <time_frame>30 days</time_frame>
    <description>readmission within 30 days for any gastrointestinal complaints or infectious complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Antibiotic Charge</measure>
    <time_frame>30 days</time_frame>
    <description>any additional antibiotics prescribed due to infectious complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interventions for postoperative abscess</measure>
    <time_frame>30 days</time_frame>
    <description>drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Perforated Appendicitis</condition>
  <condition>Postoperative Infection</condition>
  <arm_group>
    <arm_group_label>2-drug Therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>ceftriaxone/metronidazole</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1-drug Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>piperacillin-tazobactam</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piperacillin, Tazobactam Drug Combination</intervention_name>
    <description>Single drug therapy</description>
    <arm_group_label>1-drug Therapy</arm_group_label>
    <other_name>piperacillin-tazobactam</other_name>
    <other_name>Zosyn</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postoperative Perforated Appendicitis (documented by intraoperative photo)&#xD;
&#xD;
          -  Postoperative Laparoscopic Appendectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nonperforated Gangrenous Appendicitis&#xD;
&#xD;
          -  Nonperforated Purulent Appendicitis&#xD;
&#xD;
          -  Open Appendectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Phoenix Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</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>Appendicitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tazobactam</mesh_term>
    <mesh_term>Piperacillin</mesh_term>
    <mesh_term>Piperacillin, Tazobactam Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03289351
org study id: 17-011
nct id: NCT03289351
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
After appendix has been removed for perforated appendicitis, patients will receive
      postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3
      -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug
      therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a
      single-drug therapy, there are additional benefits of simplicity, compliance, and lower
      infectious complications. Currently surgeons are already using both 2-drug regimen
      (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA
      approved and regulated antibiotics for intra-abdominal infection. There is a clear need to
      compare outcomes between these two options.
The diagnosis of perforated appendicitis will be documented intraoperatively with photos of
      extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to
      121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded
      sequence model. 30 day postoperative follow up visit or calls will be made to assess and
      collect infectious complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative Intra-abdominal Abscess
time frame: 30 days
description: Intra-abdominal abscess documented by ultrasound or computerized tomography
measure: Postoperative Surgical Site Infection
time frame: 30 days
description: surgical site infections including superficial port site infection
measure: Postoperative Readmission
time frame: 30 days
description: readmission within 30 days for any gastrointestinal complaints or infectious complications
measure: Postoperative Antibiotic Charge
time frame: 30 days
description: any additional antibiotics prescribed due to infectious complications
measure: Interventions for postoperative abscess
time frame: 30 days
description: drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics
arm group label: 2-drug Therapy
arm group type: No Intervention
description: ceftriaxone/metronidazole
arm group label: 1-drug Therapy
arm group type: Experimental
description: piperacillin-tazobactam
intervention type: Drug
intervention name: Piperacillin, Tazobactam Drug Combination
description: Single drug therapy
arm group label: 1-drug Therapy
other name: piperacillin-tazobactam
other name: Zosyn
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Justin Lee, MD
role: Principal Investigator
affiliation: Phoenix Childrens Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Appendicitis
mesh term: Tazobactam
mesh term: Piperacillin
mesh term: Piperacillin, Tazobactam Drug Combination
sharing ipd: No