Syphilis Infection Clinical Trial
Official title:
Descriptive Cohort of Acquired Syphlis by Non Sexual Contact
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital de Niños Ricardo Gutierrez | Buenos Aires | Capital Federal |
Lead Sponsor | Collaborator |
---|---|
Hospital de Niños R. Gutierrez de Buenos Aires |
Argentina,
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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