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临床试验/NCT04084379
NCT04084379招募中不适用

Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases in Context of ETMIplus Program, OPS/OMS. Multicentric Study

Hospital de Niños R. Gutierrez de Buenos Aires1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
560
试验地点
1
主要终点
Implementation of Bio-molecular Techniques (PCR) for Early Diagnose of Congenital Syphilis and Chagas Diseases

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Hospital de Niños R. Gutierrez de Buenos Aires
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jaime Altcheh

Principal Investigator

Hospital de Niños R. Gutierrez de Buenos Aires

研究点 (1)

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