An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years: Healthy Carriage, Patients With Non-invasive and Invasive Pneumococcal Infections in the Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Incidence of pneumococcal infection in the Russian Federation, caused by different serotypes of Streptococcus pneumoniae
研究概览
简要总结
Pneumococcal conjugate vaccine was added to the National Immunization Program in Russia in 2014 which could affect the changes in pneumococcal serotypes in growing population. The purpose of this study is to determine the spectrum of serotypes of S. pneumoniae in patients older 18-years: in healthy carriage, in patients with non-invasive and invasive forms of pneumococcal infection. The patients will be divide into several groups: 18-64-years old, 65 years old and older, immunocompromised patients, immunocompetent patients with concomitant diseases and patients from restricted organized collectives.
This study is designed to meet the following objectives:
To estimate the spectrum of serotypes of S. pneumoniae in adult population in different regions of Russia.
详细描述
S. pneumoniae is a major cause of illness and death in children and adults worldwide. It includes 91 serotypes. The distribution of serotypes that cause disease varies by age, disease syndrome, disease severity, geographic region, and over time. Infants and young children are thought to be the main reservoir of this agent. From the colonized nasopharyngeal mucosa, pneumococci may spread by contiguous, non-invasive extension to other sites in the respiratory tract.
About 1.6 million cases of fatal pneumococcal disease occur worldwide annually, mostly in infants and the elderly.3 In addition, immunocompromised individuals of all ages, immunocompetent patients with concomitant diseases (chronic heart failure, broncho-obstructive syndrome, liquorrhea, ext.) are at increased risk.
Pneumococcal resistance to commonly used antimicrobials is a serious and increasing problem worldwide. Therefore vaccination is the most effective mechanism to reduce the incidence of pneumococcal infection in children and adult patients.
The effectiveness of pneumococcal vaccine is estimated by coverage of serotypes of S. pneumoniae. The distribution of the serotypes can be potentoinally changed because of the using of PCV in Russia.
Study design. Prospective Multicentre Microbiological study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically relevant causative isolate - The isolate must meet the laboratory criteria of S. pneumoniae and be considered the "probable causative agent" of infection.
- •Isolates from patients older 18-years with pneumococcal acute otitis media
- •Isolates from patients older 18-years with pneumococcal pneumonia
- •Isolates from patients older 18-years with invasive pneumococcal diseases (meningitis, sepsis)
- •Isolates from healthy carriage older 18-years
排除标准
- •Isolates that have been collected and/or stored prior to June 1, 2018 or later than September 30,
- •Duplicate isolates (same genus and species) obtained at any subsequent time from the same patient, regardless of susceptibility or phenotypic profile.
- •Environmental samples (non patient-derived) or surveillance cultures taken for infection control purposes.
- •Outside study group - Any isolate other than those defined by the protocol
结局指标
主要结局
Incidence of pneumococcal infection in the Russian Federation, caused by different serotypes of Streptococcus pneumoniae
时间窗: 1 year
The incidence will be detected with descriptive statistics
次要结局
- Incidence of antimicrobial resistance of serotypes of Streptococcus pneumoniae(1 year)
研究者
Roman Kozlov
President
The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC)