<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/NCT03795194</url>
  </required_header>
  <id_info>
    <org_study_id>17-055</org_study_id>
    <nct_id>NCT03795194</nct_id>
  </id_info>
  <brief_title>Antibiotic Duration in Post-appendectomy Abscess</brief_title>
  <official_title>A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess</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>No</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>
      This is a randomized study of patients 2-17 years old who are diagnosed with perforated&#xD;
      appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients&#xD;
      will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of&#xD;
      this study is to determine whether duration of antibiotic treatment at discharge demonstrates&#xD;
      significant differences in clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The central aim of this study is to determine whether duration of antibiotic treatment at&#xD;
      discharge demonstrates significant differences in primary and secondary clinical outcomes.&#xD;
      Specifically, this research aims to determine whether the readmission rate and length of stay&#xD;
      for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic&#xD;
      abscess that is treated with percutaneous drainage and are treated with a 8-day oral&#xD;
      antibiotic regimen at discharge is significantly different from those treated with a fixed&#xD;
      4-day regimen at discharge.&#xD;
&#xD;
      This study includes patients ages 2-17 years old who present with perforated appendicitis-as&#xD;
      diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen-and who&#xD;
      develop an abscess after laparoscopy that is treated with percutaneous drainage.&#xD;
&#xD;
      All post-laparoscopic abscess patients will receive the standard of care for antibiotic&#xD;
      therapy at Phoenix Children's Hospital-IV ceftriaxone/metronidazole-until afebrile and&#xD;
      tolerating food. All patients will be treated with the PCH standard of care and receive&#xD;
      in-patient treatment for abscess until afebrile.&#xD;
&#xD;
      At discharge, study patients will be randomly assigned to either an 8-day&#xD;
      ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients&#xD;
      who are allergic to ampicillin will be excluded from the study. Patients will be followed&#xD;
      thirty days post discharge to assess clinical outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to low enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 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>Hospital readmission rate</measure>
    <time_frame>30 days</time_frame>
    <description>Number of times patient is readmitted to the hospital after their laparoscopy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>How many days patient stays in the hospital if and when they are readmitted after their laparoscopy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of abdominal abscess</measure>
    <time_frame>30 days</time_frame>
    <description>Number of times patient develops abdominal abscess after discharge from hospital after their laparoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of intra-abdominal wound infection</measure>
    <time_frame>30 days</time_frame>
    <description>How many times patient develops an intra-abdominal wound infection after discharge from the hospital after their laparoscopy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Complicated Appendicitis</condition>
  <condition>Perforated Appendicitis</condition>
  <arm_group>
    <arm_group_label>8-day</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>8-day course of ampicillin clavulanate antibiotic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4-day</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>4--day course of ampicillin clavulanate antibiotic</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ampicillin/clavulanate</intervention_name>
    <description>FDA-approved antibiotic</description>
    <arm_group_label>4-day</arm_group_label>
    <arm_group_label>8-day</arm_group_label>
    <other_name>Augmentin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 2 to 17 years of age&#xD;
&#xD;
          -  Diagnosis of perforated appendicitis at laparoscopy&#xD;
&#xD;
          -  Development of a post-appendectomy abscess that is treated with percutaneous drainage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are allergic to ampicillin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig Egan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Phoenix Children's</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</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>Clavulanic Acid</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Ampicillin</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/NCT03795194
org study id: 17-055
nct id: NCT03795194
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized study of patients 2-17 years old who are diagnosed with perforated
      appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients
      will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of
      this study is to determine whether duration of antibiotic treatment at discharge demonstrates
      significant differences in clinical outcomes.
The central aim of this study is to determine whether duration of antibiotic treatment at
      discharge demonstrates significant differences in primary and secondary clinical outcomes.
      Specifically, this research aims to determine whether the readmission rate and length of stay
      for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic
      abscess that is treated with percutaneous drainage and are treated with a 8-day oral
      antibiotic regimen at discharge is significantly different from those treated with a fixed
      4-day regimen at discharge.

      This study includes patients ages 2-17 years old who present with perforated appendicitis-as
      diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen-and who
      develop an abscess after laparoscopy that is treated with percutaneous drainage.

      All post-laparoscopic abscess patients will receive the standard of care for antibiotic
      therapy at Phoenix Children's Hospital-IV ceftriaxone/metronidazole-until afebrile and
      tolerating food. All patients will be treated with the PCH standard of care and receive
      in-patient treatment for abscess until afebrile.

      At discharge, study patients will be randomly assigned to either an 8-day
      ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients
      who are allergic to ampicillin will be excluded from the study. Patients will be followed
      thirty days post discharge to assess clinical outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hospital readmission rate
time frame: 30 days
description: Number of times patient is readmitted to the hospital after their laparoscopy.
measure: Length of hospital stay
time frame: 30 days
description: How many days patient stays in the hospital if and when they are readmitted after their laparoscopy.
measure: Rate of abdominal abscess
time frame: 30 days
description: Number of times patient develops abdominal abscess after discharge from hospital after their laparoscopy.
measure: Rate of intra-abdominal wound infection
time frame: 30 days
description: How many times patient develops an intra-abdominal wound infection after discharge from the hospital after their laparoscopy.
arm group label: 8-day
arm group type: Other
description: 8-day course of ampicillin clavulanate antibiotic
arm group label: 4-day
arm group type: Other
description: 4--day course of ampicillin clavulanate antibiotic
intervention type: Drug
intervention name: ampicillin/clavulanate
description: FDA-approved antibiotic
arm group label: 4-day
arm group label: 8-day
other name: Augmentin
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Craig Egan, MD
role: Principal Investigator
affiliation: Phoenix Children's
facility: 
country: United States
responsible party type: Sponsor
mesh term: Appendicitis
mesh term: Clavulanic Acid
mesh term: Amoxicillin-Potassium Clavulanate Combination
mesh term: Clavulanic Acids
mesh term: Ampicillin
sharing ipd: No