Increasing Incidence of Complicated Pneumonia in Children in South-East Europe: a Retrospective Multi-center Analysis of Incidence, Characteristics and Outcomes

Brief Summary

Detailed Description

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 * Comparison of pre- and post- pneumococcal conjugate vaccine period (in selected countries) regarding the number of cases, isolated Streptococcus pneumoniae and antimicrobial resistance * Determining if high values of inflammatory markers in serum can be predictive factors for complicated clinical course * Evaluation of the effectiveness of the early introduction of intrapleural fibrinolytic therapy to length of hospital stay and incidence of complications (including bronchopleural fistula). * Use the systemic corticosteroids for empyema and associated necrotizing pneumonia and the risk for bronchopleural fistula * Evaluation of frequent use of antibiotics and higher prevalence of multi-drug resistant Streptococcus pneumoniae. * Determination of risk factors for surgical therapy The primary outcome, incidence of complicated community acquired pneumonia, will be compared between vaccinated and non-vaccinated groups using chi-square tests for categorical variables and t-tests for continuous variables. Secondary outcomes, such as length of hospital stay and complications, will be analyzed using ANOVA and logistic regression, adjusting for potential confounders such as age and comorbidities. Subgroup analyses will assess differences in outcomes across age groups and different vaccination periods (pre- and post- 13 valent pneumococcal conjugate vaccine). Statistical significance will be defined as p\<0.05. Statistical analyses will be performed using SPSS, version 26.

Primary Outcomes

Secondary Outcomes

• 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.)