<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/NCT04455425</url>
  </required_header>
  <id_info>
    <org_study_id>Si non sexual</org_study_id>
    <nct_id>NCT04455425</nct_id>
  </id_info>
  <brief_title>Acquired Syphlis by Non Sexual Contact</brief_title>
  <official_title>Descriptive Cohort of Acquired Syphlis by Non Sexual Contact</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Niños R. Gutierrez de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Niños R. Gutierrez de Buenos Aires</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>
      Syphilis is classically described as a sexually transmitted disease. As this source of&#xD;
      contagious has been described long ago -mainly though by observation- when children presents&#xD;
      with acquired syphilis, child abuse is always considered and must be ruled out by specialists&#xD;
      in a careful evaluation.&#xD;
&#xD;
      However, muco-cutaneous lesions can be a contagious source for congenital syphilis; therefore&#xD;
      the possibility of non-sexual transmission through intimate contact with infected people&#xD;
      through humid lesions (such as in kisses, breastfeeding, food-handling) or contaminated&#xD;
      fomites (towels, bed sheets, underwear, cups, pacifiers, cutlery) could be considered.&#xD;
      Experts worldwide have observed this non-sexual transmission, as described in many reports in&#xD;
      literature.&#xD;
&#xD;
      The investigators will study retrospectively patients from a cohort with non-sexual&#xD;
      transmission. The diagnosis criteria used for acquired syphilis were as follows: age under 18&#xD;
      years with treponemic and nontreponemic positive tests, secondary-syphilis suspicious lesions&#xD;
      and negative maternal syphilis serology. Nonsexual contagious was defined as contacts without&#xD;
      physical and psychosocial indicators of sexual abuse according to current guides. In this&#xD;
      cohort, in every case a psychosocial evaluation was completed with a written report in order&#xD;
      to evaluate sexual contact probability.&#xD;
&#xD;
      The teamo will describe these patients clinical and laboratory findings, family and close&#xD;
      acquaintances serologies and probable source of contagious.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">May 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 15, 2021</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>Describe diagnose process of a cohort of children with assumed non-sexual acquired syphilis</measure>
    <time_frame>Past 20 years</time_frame>
    <description>Describe the interdisciplinary approach of patients with acquired syphilis and how non-sexual transmission was assumed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Describe serology titers from patients with non - sexually acquired syphilis and from their close contacts</measure>
    <time_frame>Past 20 years</time_frame>
    <description>Investigators will report serology titers from patients with non - sexually acquired syphilis at diagnose and follow-up until cure, and from their close contacts at diagnose and during follow up of those resulting positive at contact screening</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Describe reported symptoms and physical findings at diagnose and during follow-up f children with assumed non-sexual acquired syphilis and their close contacts</measure>
    <time_frame>Past 20 years</time_frame>
    <description>Investigators will describe symptoms and physical findings from patients with non - sexually acquired syphilis at diagnose and follow-up until cure, and from their close contacts at diagnose and during follow up of those resulting positive at contact screening</description>
  </primary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Syphilis Acquired</condition>
  <condition>Syphilis Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children from 0 to 18 years of age assisted at Parasitoloy and Chagas department from&#xD;
        Children's Hospital in Buenos Aires, Argentina&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
        - Children with treponemic and non-treponemic positive tests with primary or&#xD;
        secondary-syphilis suspicious lesions&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        - Children with diagnose criteria positive for Congenital syphilis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Moscatelli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Niños Ricardo Gutierrez</name>
      <address>
        <city>Buenos Aires</city>
        <state>Capital Federal</state>
        <zip>1425</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Niños R. Gutierrez de Buenos Aires</investigator_affiliation>
    <investigator_full_name>Dr Jaime Altcheh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syphilis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04455425
org study id: Si non sexual
nct id: NCT04455425
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Syphilis is classically described as a sexually transmitted disease. As this source of
      contagious has been described long ago -mainly though by observation- when children presents
      with acquired syphilis, child abuse is always considered and must be ruled out by specialists
      in a careful evaluation.

      However, muco-cutaneous lesions can be a contagious source for congenital syphilis; therefore
      the possibility of non-sexual transmission through intimate contact with infected people
      through humid lesions (such as in kisses, breastfeeding, food-handling) or contaminated
      fomites (towels, bed sheets, underwear, cups, pacifiers, cutlery) could be considered.
      Experts worldwide have observed this non-sexual transmission, as described in many reports in
      literature.

      The investigators will study retrospectively patients from a cohort with non-sexual
      transmission. The diagnosis criteria used for acquired syphilis were as follows: age under 18
      years with treponemic and nontreponemic positive tests, secondary-syphilis suspicious lesions
      and negative maternal syphilis serology. Nonsexual contagious was defined as contacts without
      physical and psychosocial indicators of sexual abuse according to current guides. In this
      cohort, in every case a psychosocial evaluation was completed with a written report in order
      to evaluate sexual contact probability.

      The teamo will describe these patients clinical and laboratory findings, family and close
      acquaintances serologies and probable source of contagious.
observational model: Cohort
time perspective: Retrospective
measure: Describe diagnose process of a cohort of children with assumed non-sexual acquired syphilis
time frame: Past 20 years
description: Describe the interdisciplinary approach of patients with acquired syphilis and how non-sexual transmission was assumed
measure: Describe serology titers from patients with non - sexually acquired syphilis and from their close contacts
time frame: Past 20 years
description: Investigators will report serology titers from patients with non - sexually acquired syphilis at diagnose and follow-up until cure, and from their close contacts at diagnose and during follow up of those resulting positive at contact screening
measure: Describe reported symptoms and physical findings at diagnose and during follow-up f children with assumed non-sexual acquired syphilis and their close contacts
time frame: Past 20 years
description: Investigators will describe symptoms and physical findings from patients with non - sexually acquired syphilis at diagnose and follow-up until cure, and from their close contacts at diagnose and during follow up of those resulting positive at contact screening
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 18 Years
last name: Guillermo Moscatelli, MD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Hospital de Niños R. Gutierrez de Buenos Aires
investigator full name: Dr Jaime Altcheh
investigator title: Principal Investigator
mesh term: Syphilis