xml: <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/NCT05966454</url>
    </required_header>
    <id_info>
      <org_study_id>21-35457</org_study_id>
      <nct_id>NCT05966454</nct_id>
    </id_info>
    <brief_title>Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF</brief_title>
    <acronym>CASA RELAX</acronym>
    <official_title>Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) -A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to demonstrate the safety, efficacy, and feasibility of&#xD;
        short-course post-operative antibiotic treatment for simple and complicated appendicitis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single center, randomized controlled trial to determine if decreasing the amount of&#xD;
        antibiotics after appendicitis surgery can decrease the risk of adverse effects associated&#xD;
        with antibiotics while at the same time ensuring participant safety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 6, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Incidence of Infectious/Antibiotic Complications</measure>
      <time_frame>Up to 30 days after appendicitis surgery</time_frame>
      <description>Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participant deaths</measure>
      <time_frame>Up to 30 days after appendicitis surgery</time_frame>
      <description>Up to 30 days after appendicitis surgery</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">145</enrollment>
    <condition>Appendicitis</condition>
    <arm_group>
      <arm_group_label>Restricted Post-Operative Antibiotics Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.&#xD;
  Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Liberal Post-Operative Antibiotics Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics&#xD;
  Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Multiple standard of care antibiotics for appendicitis, at physicians' discretion</intervention_name>
      <description>Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.</description>
      <arm_group_label>Restricted Post-Operative Antibiotics Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Multiple standard of care antibiotics for appendicitis, at physicians' discretion</intervention_name>
      <description>Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.</description>
      <arm_group_label>Liberal Post-Operative Antibiotics Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age ≥ 18 years&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Planned appendectomy (laparoscopic or open)&#xD;
  &#xD;
            -  Working telephone number or reliable method to contact patient after hospital&#xD;
               discharge&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to consent&#xD;
  &#xD;
            -  Pregnant Women&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  Immunocompromised as determined by clinical team, or patients actively receiving&#xD;
               steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or&#xD;
               patients with active hematologic malignancy affecting the immune system, leukopenia,&#xD;
               or end-stage AIDS&#xD;
  &#xD;
            -  Heart failure&#xD;
  &#xD;
            -  Allergy to bupivacaine&#xD;
  &#xD;
            -  Unlikely to comply with treatment or follow-up&#xD;
  &#xD;
            -  Inpatient consultation for appendicitis&#xD;
  &#xD;
            -  Clinically suspected of sepsis based on Sepsis-3 definition&#xD;
  &#xD;
            -  Current use of antibiotics for other indications&#xD;
  &#xD;
            -  Type 1 Diabetes or uncontrolled hyperglycemia&#xD;
  &#xD;
            -  Surgeon preference&#xD;
  &#xD;
            -  Patient preference&#xD;
  &#xD;
            -  Research team unavailable&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lucy Kornblith, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lucy Kornblith, MD</last_name>
      <phone>628-206-6946</phone>
      <email>Lucy.Kornblith@ucsf.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Brenda Nunez-Garcia</last_name>
      <phone>628-206-6942</phone>
      <email>Brenda.Nunez-Garcia@ucsf.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zuckerberg San Francisco General Hospital</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94110</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lucy Kornblith, MD</last_name>
        <phone>415-206-6946</phone>
        <email>Lucy.Kornblith@ucsf.edu</email>
      </contact>
      <investigator>
        <last_name>Lucy Kornblith, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 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>Anti-Bacterial Agents</mesh_term>
      <mesh_term>Antibiotics, Antitubercular</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Patient data will be shared with Denver health and combined with data from other independent sites for final analysis</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication</ipd_time_frame>
      <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966454
  org study id: 21-35457
  nct id: NCT05966454
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to demonstrate the safety, efficacy, and feasibility of
        short-course post-operative antibiotic treatment for simple and complicated appendicitis
  This is a single center, randomized controlled trial to determine if decreasing the amount of
        antibiotics after appendicitis surgery can decrease the risk of adverse effects associated
        with antibiotics while at the same time ensuring participant safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Infectious/Antibiotic Complications
  time frame: Up to 30 days after appendicitis surgery
  description: Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.
  measure: Number of participant deaths
  time frame: Up to 30 days after appendicitis surgery
  description: Up to 30 days after appendicitis surgery
  arm group label: Restricted Post-Operative Antibiotics Group
  arm group type: Experimental
  description: Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.
  Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
  arm group label: Liberal Post-Operative Antibiotics Group
  arm group type: Active Comparator
  description: Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics
  Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.
  intervention type: Drug
  intervention name: Multiple standard of care antibiotics for appendicitis, at physicians' discretion
  description: Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.
  arm group label: Restricted Post-Operative Antibiotics Group
  intervention type: Drug
  intervention name: Multiple standard of care antibiotics for appendicitis, at physicians' discretion
  description: Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.
  arm group label: Liberal Post-Operative Antibiotics Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lucy Kornblith, MD
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Lucy Kornblith, MD
  phone: 628-206-6946
  email: Lucy.Kornblith@ucsf.edu
  last name: Brenda Nunez-Garcia
  phone: 628-206-6942
  email: Brenda.Nunez-Garcia@ucsf.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Appendicitis
  mesh term: Anti-Bacterial Agents
  mesh term: Antibiotics, Antitubercular
  sharing ipd: Yes
  ipd description: Patient data will be shared with Denver health and combined with data from other independent sites for final analysis
  ipd info type: Study Protocol
  ipd time frame: Beginning 9 months and ending 36 months following article publication
  ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose