Epidemiological Study on Invasive Bacterial Diseases (IBD)
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
- 否
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
Chiara Azzari
Full professor
Meyer Children's Hospital IRCCS
