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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04455425
Other study ID # Si non sexual
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date May 15, 2021

Study information

Verified date February 2023
Source Hospital de Niños R. Gutierrez de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers
Gender All
Age group 0 Years to 18 Years
Eligibility INCLUSION CRITERIA: - Children with treponemic and non-treponemic positive tests with primary or secondary-syphilis suspicious lesions EXCLUSION CRITERIA: - Children with diagnose criteria positive for Congenital syphilis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Hospital de Niños Ricardo Gutierrez Buenos Aires Capital Federal

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Niños R. Gutierrez de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Describe diagnose process of a cohort of children with assumed non-sexual acquired syphilis Describe the interdisciplinary approach of patients with acquired syphilis and how non-sexual transmission was assumed Past 20 years
Primary Describe serology titers from patients with non - sexually acquired syphilis and from their close contacts 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 Past 20 years
Primary Describe reported symptoms and physical findings at diagnose and during follow-up f children with assumed non-sexual acquired syphilis and their close contacts 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 Past 20 years
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