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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04137601
Other study ID # SiC cohort
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date March 30, 2020

Study information

Verified date March 2022
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 an infectious disease caused by Treponema pallidum. In children, there are two different forms of this disease; acquired syphilis and congenital syphilis, which results from transplacental transmission of spirochetes. The worldwide incidence of congenital syphilis has increased in past years, probably due to inadequate control of pregnant women and lack of early diagnose and treatment in acute infected adults. This infection can have numerous and non-specific manifestations at all stages, and may simulate other diseases, which can delay diagnose if not suspected. A high number of newborns can be asymptomatic, so diagnose is confirmed or discharged by serologic testing after 6 to 10 months of age. This study will observe the clinical presentation and the laboratory of patients with CS treated.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date March 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria: - Infants with reactive VDRL /RPR of mothers with positive serology without confirmed treatment or incomplete. - Patients with compatible clinical signs of syphils. Exclusion Criteria: - Patients with diagnosis of acquired syphilis - Patients whose medical records are missing

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires Buenos Aires

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
Other Estimate the most frequent laboratory alterations in patients with CS By analizing clinical records we will describe the laboratory findings in both symptomatic and asymptomatic children with CS. Past 30 years
Primary Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital By examining clinical records we will describe prevalence of congenital syphilis through last 30 years. Past 30 years
Secondary Describe the clinical presentation -symptoms and image findings - in children diagnosed with CS. Symptoms will be measured as present or not and described. By looking at clinical records we will describe the number of children presenting with symptoms and number of asymptomatic. We will also describe the most frequent symptoms found and other test findings. Past 30 years