<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/NCT02261896</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-CIP-2013-166</org_study_id>
    <nct_id>NCT02261896</nct_id>
  </id_info>
  <brief_title>Antibiotic Prophylaxis for Endoscopic Ultrasound Guided Fine Needle Aspiration of Pancreatic Cystic Lesions</brief_title>
  <official_title>Multicenter, Randomized and Double-blinded Clinical Trial on the Use of Antibiotic Prophylaxis for EUS Guided FNA of Pancreatic Cystic Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spanish Clinical Research Network - SCReN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the use of antibiotic prophylaxis is&#xD;
      appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic&#xD;
      ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of infection after a pancreatic cyst fine needle aspiration guided by&#xD;
      endoscopic ultrasonography (EUS-FNA) is not well known. Antibiotic prophylaxis is recommended&#xD;
      in clinical guidelines despite the lack of evidence of its usefulness.&#xD;
&#xD;
      Our hypothesis is that the risk of infection will not be higher with placebo, and risks&#xD;
      associated to the use of antibiotics might even increase with the use of prophylaxis.&#xD;
&#xD;
      The main objective of the project is to assess the risk of infection after the procedure and&#xD;
      to determine whether the use of antibiotic prophylaxis is appropriate. The study is a phase&#xD;
      IV, multicenter, double-blinded, randomized, placebo-controlled, and non-inferiority trial .&#xD;
      We have designed a study with two parallel treatment groups. Patients will be randomized to&#xD;
      the prophylaxis or to the placebo group. All patients will be followed for 21 days or until&#xD;
      resolution of complications. To evaluate this primary objective with a non inferiority study,&#xD;
      we have estimated that a total of 218 patients will be needed (109 per group) .&#xD;
&#xD;
      The main secondary objective is to assess the incidence of complications related to the use&#xD;
      of antibiotic prophylaxis (i.e. allergic reactions, secondary infections or drug-resistant&#xD;
      infections).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of infection of a pancreatic cyst or infection related to the procedure</measure>
    <time_frame>21 days</time_frame>
    <description>The infection can be defined as &quot;confirmed&quot; if there is a positive culture of the lesion content or if there is suspicion by clinical and image techniques (CT, MRI), and a positive blood culture is obtained. It will be defined as &quot;suspected&quot; when clinical and/or image is suggestive of cyst infection, but microbial confirmation is not obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk of fever</measure>
    <time_frame>21 days</time_frame>
    <description>This will be measured prior to discharge. In case of clinical suspicion of bacteraemia at any moment during the follow up, blood cultures will be obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>secondary effects, allergic reactions, and drug resistant or secondary infections</measure>
    <time_frame>21 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">226</enrollment>
  <condition>Pancreatic Cystic Lesion</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 intravenous dose followed by 1 oral dose each 12 hours (complete 3 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antibiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ciprofloxacin 400 mg intravenous one dose followed by ciprofloxacin 500 mg oral each 12 hours (complete 3 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Evaluate usefullness of antibiotic prophylaxis</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciprofloxacin</intervention_name>
    <description>Ciprofloxacine 400 mg intravenous one dose followed by ciprofloxacine oral each 12 hours (complete 3 days)</description>
    <arm_group_label>Antibiotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a pancreatic cyst requiring EUS-FNA to complete evaluation.&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Ability to understand study procedures and to comply with them for the entire length&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other co-morbidities requiring antibiotic prophylaxis for endoscopic&#xD;
             invasive procedures (such as those with cardiac valve prosthesis).&#xD;
&#xD;
          -  Cystic lesion of the intestinal wall (foregut or duplication cyst).&#xD;
&#xD;
          -  Use of antibiotic treatment for any other indication during the 5 days prior to the&#xD;
             procedure.&#xD;
&#xD;
          -  Pregnant woman.&#xD;
&#xD;
          -  Known allergy/sensitivity to ciprofloxacin.&#xD;
&#xD;
          -  Inability or unwillingness of individual or legal guardian/representative to give&#xD;
             written informed consent.&#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>Carlos Guarner-Argente, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cyst</keyword>
  <keyword>pancreatic cyst</keyword>
  <keyword>EUS-FNA</keyword>
  <keyword>antibiotic prophylaxis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciprofloxacin</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/NCT02261896
org study id: IIBSP-CIP-2013-166
nct id: NCT02261896
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether the use of antibiotic prophylaxis is
      appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic
      ultrasonography.
The incidence of infection after a pancreatic cyst fine needle aspiration guided by
      endoscopic ultrasonography (EUS-FNA) is not well known. Antibiotic prophylaxis is recommended
      in clinical guidelines despite the lack of evidence of its usefulness.

      Our hypothesis is that the risk of infection will not be higher with placebo, and risks
      associated to the use of antibiotics might even increase with the use of prophylaxis.

      The main objective of the project is to assess the risk of infection after the procedure and
      to determine whether the use of antibiotic prophylaxis is appropriate. The study is a phase
      IV, multicenter, double-blinded, randomized, placebo-controlled, and non-inferiority trial .
      We have designed a study with two parallel treatment groups. Patients will be randomized to
      the prophylaxis or to the placebo group. All patients will be followed for 21 days or until
      resolution of complications. To evaluate this primary objective with a non inferiority study,
      we have estimated that a total of 218 patients will be needed (109 per group) .

      The main secondary objective is to assess the incidence of complications related to the use
      of antibiotic prophylaxis (i.e. allergic reactions, secondary infections or drug-resistant
      infections).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Risk of infection of a pancreatic cyst or infection related to the procedure
time frame: 21 days
description: The infection can be defined as "confirmed" if there is a positive culture of the lesion content or if there is suspicion by clinical and image techniques (CT, MRI), and a positive blood culture is obtained. It will be defined as "suspected" when clinical and/or image is suggestive of cyst infection, but microbial confirmation is not obtained.
measure: Risk of fever
time frame: 21 days
description: This will be measured prior to discharge. In case of clinical suspicion of bacteraemia at any moment during the follow up, blood cultures will be obtained.
measure: secondary effects, allergic reactions, and drug resistant or secondary infections
time frame: 21 days
arm group label: Placebo
arm group type: Experimental
description: 1 intravenous dose followed by 1 oral dose each 12 hours (complete 3 days)
arm group label: Antibiotic
arm group type: Active Comparator
description: Ciprofloxacin 400 mg intravenous one dose followed by ciprofloxacin 500 mg oral each 12 hours (complete 3 days)
intervention type: Drug
intervention name: Placebo
description: Evaluate usefullness of antibiotic prophylaxis
arm group label: Placebo
intervention type: Drug
intervention name: Ciprofloxacin
description: Ciprofloxacine 400 mg intravenous one dose followed by ciprofloxacine oral each 12 hours (complete 3 days)
arm group label: Antibiotic
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos Guarner-Argente, MD, PhD
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Ciprofloxacin
sharing ipd: No