Congenital Syphilis Prospective Cohort With Retrospective Evaluation
Argentina62 participantsStarted 2019-07-01
Plain-language 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.
Who can participate
Age range
0 Days – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital
Timeframe: Past 30 years
Trial details
NCT IDNCT04137601
SponsorHospital de Niños R. Gutierrez de Buenos Aires