Pneumococcal Nasopharyngeal Colonization as Predictor of Community-Acquired Pneumonia in Adults With Chronic Diseases: A Real-word Evidence, Prospective, Observational, Multicenter, Cohort Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 810
- 试验地点
- 1
- 主要终点
- Nasopharyngeal colonization by streptococcus pneumoniae
研究概览
简要总结
Streptococcus pneumoniae (pneumococcus) is a commensal bacterium, often isolated in the nasopharynx of preschool children and older adults with weakened immune systems, a pathogen that remains the leading cause of Community-Acquired Pneumonia (CAP) and invasive pneumococcal disease (IPD) such as Sepsis and Meningitis.
CAP is the sixth leading cause of overall mortality and the first cause of infectious disease in Colombia and the world (Montúfar et al, 2013; GBD, 2016; WHO, 2018), and both its incidence and prevalence have remained stable over the past 3 decades. Likewise, CAP due to S. pnemoniae is the most common cause of lower respiratory tract infections in humans worldwide and is associated with high morbidity and mortality in patients who suffer from it.
Pneumococcus frequently colonizes the nasopharynx of children and adults and, therefore, this condition has been postulated as a risk factor for the development of CAP. There are reports of the effect of nasopharyngeal colonization in infants, but the implications of this colonization in adults, especially adults with chronic comorbidities, are not known.
Additionally, several studies point to a relationship between pathogenicity, colonization capacity, and disease severity according to the infecting pneumococcal serotype. Therefore, it is not known which pneumococcal serotypes are most frequently colonized by adults with chronic diseases (cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), renal disease (RHD), rheumatological disease (MDR), Diabetes Mellitus (DM), among others) and the potential clinical implications of this colonization.
For these reasons, this research aims to study the phenomenon of colonization by pneumococcus in patients with chronic diseases for the development of CAP, and the relationship between the virulence genes of different serotypes and the outcome in invasive pneumococcal disease (IPD).
This study is based on real evidence (from clinical practice) and translational medicine, is prospective-observational, multicenter and cohort type in consecutive patients. Thus, in a first phase the clinical observation of the subjects will be carried out, a second phase of follow-up and sampling in the patients, and a third phase of molecular analysis.
详细描述
Streptococcus pneumoniae (the pneumococcus) is responsible for more than 5 million deaths a year globally (Aliberti et al., 2016; Reyes et al., 2017). This opportunistic Gram-positive bacterium is the most frequently identified bacteria in patients with CAP, acute meningitis, and otitis in children and adults (Paterson et al., 2010; Hinojosa et al., 2014).
The pneumococcal disease has changed during the last decade due to universal pneumococcal vaccination programs, especially in children, patients with chronic pulmonary diseases, and patients older than 65 years old. Now, serotypes thought to be not clinically significant are frequently identified in patients with pneumococcal diseases (Imohl et al., 2015; Vlachopoulos et al., 2015; Cilloniz et al., 2016; Diao et al., 2016; Suzuki et al., 2017).
However, mortality and morbidity associated with pneumococcal infection in adults have remained relatively steady during the last decades (Jain et al., 2015; Bellew et al., 2018; Wunderink et al., 2018). Several hypotheses have been generated to explain this phenomenon. Among the most studied, researchers have documentedthat circulating pneumococcal serotypes are different now, and thus, currently available vaccines may not be as useful to prevent invasive pneumococcal diseases now (Aliberti et al., 2013; Cilloniz et al., 2016).
Moreover, adults are not frequently vaccinated with the pneumococcal vaccine, and only a very restrictive group of patients receive the vaccine. In Colombia, it is not known whether even that restrictive group of adults with an indication for a pneumococcal vaccine have been vaccinated, following national and international guidelines. More importantly, it is unknown whether other groups of patients with chronic medical diseases might benefit from receiving this vaccine.
Importantly, it is also unknown, which are the most prevalent serotypes causing colonization and invasive infections in adults with chronic diseases in Colombia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age or older.
- •Patients attending cardiology, pulmonology, endocrinology or rheumatology programs at the centers participating in the study.
- •Patients with vaccination information available and confirmed in the medical records (in addition it will be confirmed at the time of the interview during the study enrollment consultation).
- •Patients who sign the informed consent approved for this purpose.
排除标准
- •Patients with a diagnosis of CAP prior to 90 days from the time of enrollment in the study.
- •Patients admitted to hospital during the 7 days prior to enrollment in the study.
- •Patients with any clinical or manifest limitation to provide biological samples.
结局指标
主要结局
Nasopharyngeal colonization by streptococcus pneumoniae
时间窗: 2 years
Definition: Colonization by S. pneumoniae in the nasopharyngeal tissue will be determined when using the traditional culture method and molecular biology (real time - PCR), the pneumococcus growth with a density of more than 10 (3) Colony-forming units (CFU). Then, using molecular biology (MS-PCR) and reaction quellung, S. pneumoniae isolated will be further characterized to determine the pneumococcal serotypes. Outcome measure: • Pneumococcal nasopharyngeal colonization prevalence of period in Adults With Chronic Diseases (PNCP) : PNCP = Pneumococcal isolates with bacteriological positive testing done during the study period / Total number of subjects enrolled in the study period. Statistic analysis: categorical variables will be expressed as counts (percentages), will be compared between groups using the Chi-squared test.
次要结局
- Risk of Development of community-acquired pneumonia (CAP)(2 years)
- Risk of Development of Invasive Pneumococcal Disease (IPD)(2 years)