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临床试验/NCT06322277
NCT06322277Unknown不适用

The Regional Pediatric Network and the Use of Low-cost Molecular Diagnostic Techniques Cost as a New Management and Surveillance Model for Diseases Preventable by Vaccinations.

Meyer Children's Hospital IRCCS4 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1
试验地点
4
主要终点
Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae.

研究概览

简要总结

Vaccine-preventable disease (VPD) surveillance should be a priority throughout the world. In Italy, however, there is limited attention to the epidemiology of VPDs, with the consequence that their incidence is largely underestimated. Although notification of vaccine-preventable diseases is mandatory, very often the etiologic agents causing VPDs are not identified the etiological agents causing the major and most severe infectious diseases in childhood. Several reasons underlie the underestimation. For example, not having a good surveillance system does not allow us to organize a sustainable prevention project for example based on on the introduction of new vaccinations. For example the limited use of low-cost high-sensitivity techniques such as real-time PCR, which could, if more widely used, improve pathogen identification with 3 times the sensitivity of standard cultural methods. Therefore, the idea of this multicenter, biological sample study is to take advantage of the regional pediatric network with the goal of improving VPD surveillance and increase awareness of the importance of surveillance of preventable diseases with the vaccine within the pediatric network.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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
否

入选标准

  • •Subjects aged 0-18 years with infectious disease (bacterial or viral) diagnosed by molecular techniques at the AOU Meyer Immunology Laboratory
  • •Obtaining informed consent

排除标准

  • •Individuals with concomitant diseases such as cystic fibrosis, known immunodeficiency, or with infection suspected nosocomial (hospitalization or hospital admission within 15 days prior to the onset of symptoms) will be excluded from the study

研究组 & 干预措施

Patients with viral/bacterial infection

Other

干预措施: Analysis of biological sample (Other)

结局指标

主要结局

Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae.

时间窗: After 3 years from the beginning of the study

Molecular surveillance data analysis of pertussis, respiratory virus disease, invasive bacterial diseases. We will measure the incidence rate of predictable disease with vaccination, stratifying by biological sex, age, other risk factors, and severity of infection during the project. (IBD) due to capsule bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae) and other vaccine-preventable infections (e.g., viral flu)

次要结局

  • Frequency of principal serotype, serogroups of pathogens causative for VPDs.(After 3 years from the beginning of the study)
  • Number of meeting to diffuse the NETVAC results in Tuscany network.(After 3 years and 6 months from the beginning of the study)

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Resti

Principal Investigator

Meyer Children's Hospital IRCCS

研究点 (4)

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