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

Last updated: February 28, 2023
Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sexually Transmitted Diseases (Stds)

Gynecological Infections

Rash

Treatment

N/A

Clinical Study ID

NCT04084379
ETMIplus ChC/SiC
  • Ages 1-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Child under 1 year of age, born from mother positive for syphilis not treated orinadequately treated during pregnancy
  • Patients with acquired syphilis
  • Child under 1 year of age, born from mother with positive serology test for Chagas

Exclusion

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 resultsinterpretation.

Study Design

Total Participants: 560
Study Start date:
July 01, 2019
Estimated Completion Date:
September 01, 2024

Connect with a study center

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

    Buenos Aires, 1425
    Argentina

    Active - Recruiting

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