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.
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
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
Massimo Resti
Principal Investigator
Meyer Children's Hospital IRCCS
