Congenital Syphilis Prospective Cohort With Retrospective Evaluation

NCT ID: NCT04137601

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Syphilis, Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de NiƱos R. Gutierrez de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Dr Jaime Altcheh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Altcheh, Dr

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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SiC cohort

Identifier Type: -

Identifier Source: org_study_id

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