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临床试验/NCT06322290
NCT06322290招募中不适用

Epidemiological Study on Invasive Bacterial Diseases (IBD)

Meyer Children's Hospital IRCCS37 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2021年12月9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
5,000
试验地点
37
主要终点
Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age.

研究概览

简要总结

Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

详细描述

Pathogen identification by culture methods has been shown to be unsatisfactory, as antibiotic therapy carried out in patients before hospitalization prevents bacterial culture development and subsequent typing in many cases. In addition, technical problems due to sample collection, storage and transport reduce germ viability leading to false negatives in pathogen identification by culture methods. In contrast, molecular diagnosis allows germ identification on biological samples even in the absence of germ viability, thus enabling more accurate diagnosis.

Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiological trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.In 2006, the AOU Meyer Immunology Laboratory received a grant from the National Center for Disease Prevention and Control (NCDC) to develop a molecular diagnostic method for surveillance of invasive infections with Neisseria meningitidis (meningococcal,) Streptococcus pneumoniae (pneumococcus) and Haemophilus influenzae (hemophilus) that would allow identification of the germ on biological samples even in the absence of germ viability, with a view to improving surveillance, prevention and treatment strategies. The project involved performing molecular diagnostic tests on samples from patients referred to hospitals in the Tuscany Region and outside the region. The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

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 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI

排除标准

  • Other type of bacterial infections.

结局指标

主要结局

Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age.

时间窗: Through study completion, an average of 1 year

Frequencies of Infective Bacterial Diseases cases from Neisseria meningitidis in Italy (meningococcus)

Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age.

时间窗: Through study completion, an average of 1 year

Monitor the trend of Infective Bacterial Diseases cases Streptococcus pneumoniae (pneumococcus) in Italy, during pediatric age.

Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age.

时间窗: Through study completion, an average of 1 year

Frequencies of Infective Bacterial Diseases cases from Haemophilus influenzae (hemophilus) in Italy

次要结局

  • Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy(Through study completion, an average of 1 yeary)
  • Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae.(Through study completion, an average of 1 year)
  • Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae.(Through study completion, an average of 1 year)

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

Chiara Azzari

Full professor

Meyer Children's Hospital IRCCS

研究点 (37)

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