Syphilis, CongenitalNCT04137601
Congenital Syphilis Prospective Cohort With Retrospective Evaluation
An observational study of Syphilis, Congenital, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 0 days to 1 year
- Conditions the study is for
- Syphilis, Congenital
- How many people
- 62 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2019to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: In older children, the sexual route for abuse will be ruled out as a means of interrogation infection and analysis of family dynamics by a multidisciplinary team.
Who may be able to join
- Infants with reactive VDRL /RPR of mothers with positive serology without confirmed treatment or incomplete.
- Patients with compatible clinical signs of syphils.
Who cannot join
- Patients with diagnosis of acquired syphilis
- Patients whose medical records are missing
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, 1425
About this study
Official title: Congenital Syphilis at Third-level Pediatric Hospital. A Prospective Cohort With Retrospective Evaluation Study of the Last Three Decades.
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.
Read more
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.
- Conditions
- Syphilis, Congenital
- Keywords
- Congenital syphilis, VDRL, CSF, Clinical manifestations
- Medical subject headings
- Syphilis, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Past 30 years
Secondary outcomes (1)
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.
Measured: Past 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syphilis, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires
- Investigators
- Jaime Altcheh, Dr, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137601
- Sponsor's protocol ID
- SiC cohort
- Status last verified
- Mar 2022
- First submitted
- 22 Oct 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Syphilis at Third-level Pediatric Hospital. A Prospective Cohort With Retrospective Evaluation Study of the Last Three Decades.
- ClinicalTrials.gov ID
- NCT04137601
- Acronym / sponsor ID
- SiC cohort
- Conditions
- Syphilis, Congenital
- Keywords
- Congenital syphilis, VDRL, CSF, Clinical manifestations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In older children, the sexual route for abuse will be ruled out as a means of interrogation infection and analysis of family dynamics by a multidisciplinary team.
Key inclusion criteria (2 listed)
- Infants with reactive VDRL /RPR of mothers with positive serology without confirmed treatment or incomplete.
- Patients with compatible clinical signs of syphils.
Key exclusion criteria (2 listed)
- Patients with diagnosis of acquired syphilis
- Patients whose medical records are missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital
Time frame: Past 30 years
By examining clinical records we will describe prevalence of congenital syphilis through last 30 years.
1 secondary outcome
Describe the clinical presentation -symptoms and image findings - in children diagnosed with CS. Symptoms will be measured as present or not and described.
Time frame: Past 30 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Altcheh, Dr principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis, Congenital, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital (time frame: Past 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.