NCT04455425

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

June 29, 2020

Last Update Submit

February 28, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • \- Children with diagnose criteria positive for Congenital syphilis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Niños Ricardo Gutierrez

Buenos Aires, Buenos Aires F.D., 1425, Argentina

Location

Study Officials

  • Guillermo Moscatelli, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 2, 2020

Study Start

July 15, 2020

Primary Completion

April 15, 2021

Study Completion

May 15, 2021

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations