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

NCT ID: NCT04084379

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 560 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2024-09-01

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.

Conditions

Chagas Disease; Syphilis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Niños R. Gutierrez de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Dr Jaime Altcheh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Buenos Aires, , Argentina

Site Status: RECRUITING

Countries

Argentina

Facility Contacts

Altcheh, Dr

Role: primary

jaltcheh@gmail.com

54-11-4964-3093

Other Identifiers

ETMIplus ChC/SiC

Identifier Type: -

Identifier Source: org_study_id