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CompletedNCT04455425Updated Mar 1, 2023

Acquired Syphlis by Non Sexual Contact

An observational study in Syphilis Acquired and Syphilis Infection, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Completed at 1 site in Argentina. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
24
Ages
0 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Syphilis Acquired
  • Syphilis Infection

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03

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children from 0 to 18 years of age assisted at Parasitoloy and Chagas department from Children's Hospital in Buenos Aires, Argentina

Inclusion criteria

  • Children with treponemic and non-treponemic positive tests with primary or secondary-syphilis suspicious lesions

Exclusion criteria

EXCLUSION CRITERIA:

  • Children with diagnose criteria positive for Congenital syphilis
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
24 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Past 20 years

  2. 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

    Time frame: Past 20 years

  3. 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

    Time frame: Past 20 years

06

Study locations

1 site
  • Hospital de Niños Ricardo Gutierrez
    Buenos Aires, Capital Federal 1425, Argentina
07

Registry details

Key details

Study ID
NCT04455425
Lead sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Responsible party
Dr Jaime Altcheh (Principal Investigator, Hospital de Niños R. Gutierrez de Buenos Aires) — Principal investigator
First posted
Jul 2, 2020
Start date
Jul 15, 2020
Primary completion
Apr 15, 2021
Completion
May 15, 2021
Last update
Mar 1, 2023

Study contacts

Guillermo Moscatelli, MD
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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