Chagas DiseaseNCT04084379
Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases
An observational study of Chagas Disease and Syphilis, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
Trial summary
Chagas disease and syphilis are considered a mayor public health problem worldwide. Both pathologies affect socio-economic vulnerable population and they are both transmitted congenitally, causing an alarming increasing number of infected newborns. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Chagas Disease, Syphilis
- How many people
- 560 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2019to 1 Sep 2024
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Population of this study are children born from mother positive for syphilis or Chagas diseases, with congenital infection suspected and children with acquired syphilis. They will be recruited at five centers from different geographical areas of Argentina
Who may be able to join
- Child under 1 year of age, born from mother positive for syphilis not treated or inadequately treated during pregnancy
- Patients with acquired syphilis
- Child under 1 year of age, born from mother with positive serology test for Chagas
Who cannot join
- Patients who had received treatment for syphilis or Chagas previously
- Patients who are not able to complete scheduled visits
- Other diseases that could difficult implementation of this protocol or results interpretation.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, 1425
Altcheh, Dr, 54-11-4964-3093, jaltcheh@gmail.com
Jaime Altcheh, Dr
About this study
Official title: Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases in Context of ETMIplus Program, OPS/OMS. Multicentric Study
Chagas disease and syphilis are considered a mayor public health problem worldwide. Both pathologies affect socio-economic vulnerable population and they are both transmitted congenitally, causing an alarming increasing number of infected newborns. The current diagnostic methods for these diseases are based on serology follow-up until 8 to 10 months from birth, which considering the population usually involved and their scarce resources, usually translates in loosing continuity in their controls and follow-up.
Chagas prevalence in pregnant women is 4% with an incidence of Congenital Chagas disease of 1500 annual cases. From those, only 1 third are diagnosed. In the investigators and other authors experience, the detection of DNA of Trypanosoma cruzi by PCR shows an elevation of parasitemia at birth, with a peak at the first month of life.
Read more
Syphilis is a re-emergent pathology, preventable and curable when diagnose is achieved early at the beginning of pregnancy.. The cost-effectiveness of performing screening for this infection is widely demonstrated, preventing high morbi-mortality for children when applied to pregnant women.
For both syphilis and Chagas diagnosis, there are some studies comparing PCR follow-up with conventional serology, but none were validated and there is still need to bring more evidence in order to modify current practice. The investigators propose a sequential study of PCR for Tryipanosoma cruzi and Treponema pallidum from birth, believing this will increase sensitivity of congenital Chagas and syphilis diagnose and improve follow-up of these patients.
- Conditions
- Chagas Disease, Syphilis
- Keywords
- congenital chagas disease, congenital syphilis, Chagas PCR diagnose, Syphilis PCR diagnose, Children
- Medical subject headings
- Chagas Disease, Syphilis, Syphilis, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of Bio-molecular Techniques (PCR) for Early Diagnose of Congenital Syphilis and Chagas Diseases
Evaluate PCR sensitivity, specificity, PPV and NPP in diagnose of congenital syphilis and congenital Chagas diseases and compare it with current methods. The investigators will measure PCR titles during one year in each patient, and then compare results with serologies, in order to assess if PCR positivization and negativization occurs earlier than current methods. This may allow physicians to shorten time required for follow-up in these patients.
Measured: 2 years
Secondary outcomes (2)
Implementation of Bio-molecular Techniques (PCR) as terapeutic response biomarker for Congenital Syphilis and Chagas Disease
Investigators will evaluate the utility of PCR as an early biomarker of terapeutic response and compare it to serology for T.pallidum and T. cruzi during and after treatment. This could prevent unnecessary prolonged treatments, and could also allow early diagnose for treatment failures.
Measured: 2 years
Identification of different genotypes of T.pallidum in samples to create a database of T.pallidum genotypes
Identification of different genotypes of T.pallidum in samples taken from active skin lessions and blood samples, in order to create a data base of T.pallidum genotypes causing congenital syphilis and acquired syphilis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas DiseaseStudies 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
- 560 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084379
- Sponsor's protocol ID
- ETMIplus ChC/SiC
- Status last verified
- Feb 2023
- First submitted
- 5 Sep 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases in Context of ETMIplus Program, OPS/OMS. Multicentric Study
- ClinicalTrials.gov ID
- NCT04084379
- Acronym / sponsor ID
- ETMIplus ChC/SiC
- Conditions
- Chagas Disease, Syphilis
- Keywords
- congenital chagas disease, congenital syphilis, Chagas PCR diagnose, Syphilis PCR diagnose, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 Sep 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.
Chagas disease and syphilis are considered a mayor public health problem worldwide. Both pathologies affect socio-economic vulnerable population and they are both transmitted congenitally, causing an alarming increasing number of infected newborns. The current diagnostic methods for these diseases are based on serology follow-up until 8 to 10 months from birth, which considering the population usually involved and their scarce resources, usually translates in loosing continuity in their controls and follow-up.
Chagas prevalence in pregnant women is 4% with an incidence of Congenital Chagas disease of 1500 annual cases. From those, only 1 third are diagnosed. In the investigators and other authors experience, the detection of DNA of Trypanosoma cruzi by PCR shows an elevation of parasitemia at birth, with a peak at the first month of life.
Syphilis is a re-emergent pathology, preventable and curable when diagnose is achieved early at the beginning of pregnancy.. The cost-effectiveness of performing screening for this infection is widely demonstrated, preventing high morbi-mortality for children when applied to pregnant women.
For both syphilis and Chagas diagnosis, there are some studies comparing PCR follow-up with conventional serology, but none were validated and there is still need to bring more evidence in order to modify current practice. The investigators propose a sequential study of PCR for Tryipanosoma cruzi and Treponema pallidum from birth, believing this will increase sensitivity of congenital Chagas and syphilis diagnose and improve follow-up of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Population of this study are children born from mother positive for syphilis or Chagas diseases, with congenital infection suspected and children with acquired syphilis. They will be recruited at five centers from different geographical areas of Argentina
Key inclusion criteria (3 listed)
- Child under 1 year of age, born from mother positive for syphilis not treated or inadequately treated during pregnancy
- Patients with acquired syphilis
- Child under 1 year of age, born from mother with positive serology test for Chagas
Key exclusion criteria (3 listed)
- Patients who had received treatment for syphilis or Chagas previously
- Patients who are not able to complete scheduled visits
- Other diseases that could difficult implementation of this protocol or results interpretation.
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
Implementation of Bio-molecular Techniques (PCR) for Early Diagnose of Congenital Syphilis and Chagas Diseases
Time frame: 2 years
Evaluate PCR sensitivity, specificity, PPV and NPP in diagnose of congenital syphilis and congenital Chagas diseases and compare it with current methods. The investigators will measure PCR titles during one year in each patient, and then compare results with serologies, in order to assess if PCR positivization and negativization occurs earlier than current methods. This may allow physicians to shorten time required for follow-up in these patients.
2 secondary outcomes
Implementation of Bio-molecular Techniques (PCR) as terapeutic response biomarker for Congenital Syphilis and Chagas Disease
Time frame: 2 years
Identification of different genotypes of T.pallidum in samples to create a database of T.pallidum genotypes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, Argentina
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 Chagas Disease and Syphilis, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation of Bio-molecular Techniques (PCR) for Early Diagnose of Congenital Syphilis and Chagas Diseases (time frame: 2 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 1 Mar 2023.