<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/NCT04489979</url>
  </required_header>
  <id_info>
    <org_study_id>0012-20-HYMC</org_study_id>
    <nct_id>NCT04489979</nct_id>
  </id_info>
  <brief_title>Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis</brief_title>
  <official_title>Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some children are admitted to pediatric emergency department due to epididymitis or orchitis.&#xD;
      Some of them are treated by analgetics only whie some are treated by analgetics with&#xD;
      antibiotics. The study will compare clinical presentation between groups and will compare&#xD;
      pediatric urologic outpatient clinic follow up findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some children are admitted to pediatric emergency department due to epididymitis or orchitis.&#xD;
      Some of them are treated by analgetics only whie some are treated by analgetics with&#xD;
      antibiotics. The study will compare clinical presentation between groups and will compare&#xD;
      pediatric urologic outpatient clinic follow up findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Healing</measure>
    <time_frame>1 month</time_frame>
    <description>No symptoms any more</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Epididymitis Orchitis</condition>
  <arm_group>
    <arm_group_label>Analgetics only</arm_group_label>
    <description>Children with epididymitis / orchitis treated by analgetics only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Analgetics and antibiotics</arm_group_label>
    <description>Children with epididymitis / orchitis treated by analgetics and antibiotics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Antibiotics</intervention_name>
    <description>Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.</description>
    <arm_group_label>Analgetics and antibiotics</arm_group_label>
    <arm_group_label>Analgetics only</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male children who were admitten to pediatric emergency department due to epididymitis or&#xD;
        orchitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children admitted to pediatric emergency department due to epididymitis or&#xD;
             orchitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No sonographic or laboratory exam&#xD;
&#xD;
          -  Antibiotic treatment before diagnosis&#xD;
&#xD;
          -  No outpatient follow-up&#xD;
&#xD;
          -  Known urologic congenital malformations&#xD;
&#xD;
          -  Admission to inpatient department or emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only males have testicles</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erez Nadir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hillel Yaffe medical center</name>
      <address>
        <city>H̱adera</city>
        <state>Hadera</state>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Lau P, Anderson PA, Giacomantonio JM, Schwarz RD. Acute epididymitis in boys: are antibiotics indicated? Br J Urol. 1997 May;79(5):797-800. doi: 10.1046/j.1464-410x.1997.00129.x.</citation>
    <PMID>9158522</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillel Yaffe Medical Center</investigator_affiliation>
    <investigator_full_name>Erez Nadir, MD</investigator_full_name>
    <investigator_title>Neonatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Orchitis</mesh_term>
    <mesh_term>Epididymitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</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/NCT04489979
org study id: 0012-20-HYMC
nct id: NCT04489979
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Some children are admitted to pediatric emergency department due to epididymitis or orchitis.
      Some of them are treated by analgetics only whie some are treated by analgetics with
      antibiotics. The study will compare clinical presentation between groups and will compare
      pediatric urologic outpatient clinic follow up findings.
Some children are admitted to pediatric emergency department due to epididymitis or orchitis.
      Some of them are treated by analgetics only whie some are treated by analgetics with
      antibiotics. The study will compare clinical presentation between groups and will compare
      pediatric urologic outpatient clinic follow up findings.
observational model: Cohort
time perspective: Retrospective
measure: Healing
time frame: 1 month
description: No symptoms any more
arm group label: Analgetics only
description: Children with epididymitis / orchitis treated by analgetics only.
arm group label: Analgetics and antibiotics
description: Children with epididymitis / orchitis treated by analgetics and antibiotics.
intervention type: Other
intervention name: Antibiotics
description: Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.
arm group label: Analgetics and antibiotics
arm group label: Analgetics only
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Only males have testicles
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Erez Nadir, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
facility: 
country: Israel
citation: Lau P, Anderson PA, Giacomantonio JM, Schwarz RD. Acute epididymitis in boys: are antibiotics indicated? Br J Urol. 1997 May;79(5):797-800. doi: 10.1046/j.1464-410x.1997.00129.x.
PMID: 9158522
responsible party type: Principal Investigator
investigator affiliation: Hillel Yaffe Medical Center
investigator full name: Erez Nadir, MD
investigator title: Neonatologist
mesh term: Orchitis
mesh term: Epididymitis
mesh term: Anti-Bacterial Agents
sharing ipd: No