Clinical trial NCT04084379: Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chagas Disease
Syphilis
Keywords: congenital chagas disease
congenital syphilis
Chagas PCR diagnose
Syphilis PCR diagnose
Children
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 560
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Implementation of Bio-molecular Techniques (PCR) for Early Diagnose of Congenital Syphilis and Chagas Diseases
timeFrame: 2 years
Secondary outcomes:
measure: Implementation of Bio-molecular Techniques (PCR) as terapeutic response biomarker for Congenital Syphilis and Chagas Disease
timeFrame: 2 years
measure: Identification of different genotypes of T.pallidum in samples to create a database of T.pallidum genotypes
timeFrame: 2 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Study officials:
References: