Increasing Incidence of Complicated Pneumonia in Children in South-East Europe: a Retrospective Multi-center Analysis of Incidence, Characteristics and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of children hospitalized and diagnosed with complicated (particularly necrotizing) community-acquired pneumonia relative to the total number of children hospitalized for community-acquired pneumonia over the study period and for each year
研究概览
简要总结
This retrospective observational study aims to evaluate clinical course of complicated community acquired pneumonia in children, particularly focusing on necrotizing pneumonia cases, as well as determination of etiological agents (viruses and bacteria) and its association to severity and outcomes of the disease. Furthermore, therapeutic approach, complications, short-term and long-term outcomes and the prevention of the disease are to be assessed. The study will encompass data from pediatric centers in the South-East Europe willing to participate in the study, encompassing ten-year period of time.
详细描述
Children aged from 1 month to 18 years of age diagnosed with complicated community acquired pneumonia (pneumonia with parapneumonic effusion, necrotizing pneumonia or lung abscess) who were admitted from January 1st 2014 to April 30th 2024 to participating centers will be considered eligible for this multi-centric retrospective study.
The medical charts of all selected patients will be reviewed by medical professionals at each center and data collected in a standardized electronic database specifically created for this study to ensure consistency. Data quality will be internally monitored by the lead investigator, with periodic data validation checks to identify and resolve inconsistencies. All patient information will be stored securely in accordance with local regulations.
For every enrolled patient the following variables will be obtained: age, gender, date of admission, onset of symptoms and antibiotic treatment prior to hospitalization, comorbidities, immunization status, vital parameters on admission (heart rate, respiratory rate and percutaneous blood oxygen saturation), laboratory tests results on admission (white blood cells count, C-reactive protein concentration, blood gases, serum albumin concentration, serum lactate dehydrogenase activity), biochemical and cytological characteristics of pleural effusion (if applicable), microbiological results (culture and polymerase chain reaction) with Streptococcus pneumoniae serotype and its antimicrobial susceptibility to antibiotics, imaging (chest X-ray, CT scan, lung ultrasound), flexible bronchoscopy findings (if applicable), treatment modalities encompassing length of antibiotic therapy, use of systemic steroids, thoracic drainage, application of intrapleural fibrinolytics and surgical treatment, respiratory support information, length of hospitalization and intensive care unit stay, complications, chest radiography at follow up (at 3, 6, 12 months after discharge is available) and information on fatal/nonfatal outcome.
Primary outcome The primary outcome of this study is to estimate incidence and provide information on clinical characteristics of complicated community acquired pneumonia, particularly necrotizing pneumonia, in children and also identify possible association between microbiological isolates, immunization status and severity of clinical course.
Secondary outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of children hospitalized and diagnosed with complicated (particularly necrotizing) community-acquired pneumonia relative to the total number of children hospitalized for community-acquired pneumonia over the study period and for each year
时间窗: January 1st 2014 to April 30th 2024
The values will be expressed as percentage. Incidence rates will be calculated for each year and across different centers.
次要结局
- Distribution of different types of complicated community acquired pneumonia(from hospital admission to discharge, lasting on average from one to three weeks.)
- Number of participants vaccinated against Streptococcus pneumoniae with pneumococcal conjugate vaccine and distribution of vaccines covering for different number of serotypes(from hospital admission to discharge, lasting on average from one to three weeks.)
- Distribution of different Streptococcus pneumoniae vaccines covering for different number of serotypes(from hospital admission to discharge, lasting on average from one to three weeks.)
- Serum lactate dehydrogenase activity(recorded at the time of hospital admission.)
- Duration of symptoms before hospitalization(recorded at the time of hospital admission.)
- Percutaneous oxygen saturation (SpO2)(recorded at the time of hospital admission.)
- C-reactive protein concentration(recorded at the time of hospital admission.)
- Heart rate(recorded at the time of hospital admission.)
- Respiratory rate(recorded at the time of hospital admission.)
- White blood cells count(recorded at the time of hospital admission.)
- Positivity of pleural fluid bacteriological culture and PCR (polymerase chain reaction) to bacteria (if done)(from hospital admission to discharge, lasting on average from one to three weeks.)
- Positivity of blood bacteriological culture and PCR (polymerase chain reaction) to bacteria (if done)(from hospital admission to discharge, lasting on average from one to three weeks.)
- Blood serum albumin concentration(recorded at the time of hospital admission.)
- Positivity of bronchoalveolar lavage fluid bacteriological culture and PCR (polymerase chain reaction) to bacteria (if done)(from hospital admission to discharge, lasting on average from one to three weeks.)
- Positivity to viral causative agents on PCR (polymerase chain reaction) (if done)(from hospital admission to discharge, lasting on average from one to three weeks.)
- Identification of specific Streptococcus pneumoniae serotype if isolated (if serotyping done)(from hospital admission to discharge, lasting on average from one to three weeks.)
- Resistance of Streptococcus pneumoniae to penicillin and ceftriaxone, and resistance of Staphylococcus aureus to methicillin(from hospital admission to discharge, lasting on average from one to three weeks.)
- Duration of antibiotic therapy (peroral and intravenous)(from hospital admission to discharge, lasting on average from one to three weeks, and at first follow-ups.)
- Use of systemic corticosteroids(from hospital admission to discharge, lasting on average from one to three weeks.)
- Level of respiratory support(from hospital admission to discharge, lasting on average from one to three weeks.)
- Number of participants requiring pleural drainage(from hospital admission to discharge, lasting on average from one to three weeks.)
- Duration of pleural drainage(from hospital admission to discharge, lasting on average from one to three weeks.)
- Number of participants in whom intrapleural fibrinolytics were administered(from hospital admission to discharge, lasting on average from one to three weeks.)
- Number of participants in whom surgical treatment was performed(from hospital admission to discharge, lasting on average from one to three weeks.)
- Number of patients with complications(from hospital admission to discharge, lasting on average from one to three weeks.)
- Number of patients with fatal outcome of the disease(from hospital admission to discharge, lasting on average from one to three weeks.)
- Radiological resolution on follow-ups(Follow-ups at 3, 6 and 12 months after discharge if available.)
研究者
Aleksandar Sovtic
Ass.Prof.
Mother and Child Health Institute of Serbia Dr Vukan Cupic