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

NCT04084379 | Unknown DMC

• 1 other identifier: ETMIplus ChC/SiC
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

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

Keywords

congenital chagas disease; congenital syphilis; Chagas PCR diagnose; Syphilis PCR diagnose; Children

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Implementation of Bio-molecular Techniques (PCR) as terapeutic response biomarker for Congenital Syphilis and Chagas Disease

  2 years

• Identification of different genotypes of T.pallidum in samples to create a database of T.pallidum genotypes

  2 years

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Study Sites (1)

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

Buenos Aires, 1425, Argentina

RECRUITING

MeSH Terms

Conditions

Chagas Disease; Syphilis; Syphilis, Congenital

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: September 1, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

AR (1)