Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires (Other)

Overall Status

Recruiting

CT.gov ID

NCT04084379

Collaborator

(none)

560

Enrollment

Location

Anticipated Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Chagas Disease Syphilis

Study Design

Study Type:

Observational

Anticipated Enrollment :

560 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jul 30, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

Implementation of Bio-molecular Techniques (PCR) for Early Diagnose of Congenital Syphilis and Chagas Diseases [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.

Secondary Outcome Measures

Implementation of Bio-molecular Techniques (PCR) as terapeutic response biomarker for Congenital Syphilis and Chagas Disease [2 years]
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.
Identification of different genotypes of T.pallidum in samples to create a database of T.pallidum genotypes [2 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.