Clinical trial NCT06657898: Complicated Pneumonia (CP) in Children in South-East Europe
Official title: Increasing Incidence of Complicated Pneumonia in Children in South-East Europe: a Retrospective Multi-center Analysis of Incidence, Characteristics and Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia, Necrotizing
Lung Abscess
Empyema, Pleural
Keywords: pneumonia in children
necrotizing pneumonia
empyema
lung abscess
Lead sponsor: Mother and Child Health Institute of Serbia Dr Vukan Cupic
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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) and who were admitted from January 1st 2014 to April 30th 2024 in participating centers will be considered eligible for the study.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria

* Children aged 1 month to 18 years of age
* Children diagnosed with complicated community acquired pneumonia (pneumonia with parapneumonic effusion, necrotizing pneumonia and lung abscess)
* Children who were hospitalized from January 1st 2014 to April 30th 2024 and required at least 24 hours of hospital stay

Exclusion Criteria

* Children with increased risk for severe lung infections (cystic fibrosis, primary ciliary dyskinesia, immunodeficiencies, congenital lung abnormalities, neurological conditions, chemotherapy)
* Children with hospital-acquired pneumonia

Primary outcomes:
measure: 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
timeFrame: January 1st 2014 to April 30th 2024
Secondary outcomes:
measure: Distribution of different types of complicated community acquired pneumonia
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Number of participants vaccinated against Streptococcus pneumoniae with pneumococcal conjugate vaccine and distribution of vaccines covering for different number of serotypes
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Distribution of different Streptococcus pneumoniae vaccines covering for different number of serotypes
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Duration of symptoms before hospitalization
timeFrame: recorded at the time of hospital admission.
measure: Percutaneous oxygen saturation (SpO2)
timeFrame: recorded at the time of hospital admission.
measure: Heart rate
timeFrame: recorded at the time of hospital admission.
measure: Respiratory rate
timeFrame: recorded at the time of hospital admission.
measure: White blood cells count
timeFrame: recorded at the time of hospital admission.
measure: C-reactive protein concentration
timeFrame: recorded at the time of hospital admission.
measure: Blood serum albumin concentration
timeFrame: recorded at the time of hospital admission.
measure: Serum lactate dehydrogenase activity
timeFrame: recorded at the time of hospital admission.
measure: Positivity of pleural fluid bacteriological culture and PCR (polymerase chain reaction) to bacteria (if done)
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Positivity of blood bacteriological culture and PCR (polymerase chain reaction) to bacteria (if done)
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Positivity of bronchoalveolar lavage fluid bacteriological culture and PCR (polymerase chain reaction) to bacteria (if done)
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Positivity to viral causative agents on PCR (polymerase chain reaction) (if done)
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Identification of specific Streptococcus pneumoniae serotype if isolated (if serotyping done)
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Resistance of Streptococcus pneumoniae to penicillin and ceftriaxone, and resistance of Staphylococcus aureus to methicillin
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Duration of antibiotic therapy (peroral and intravenous)
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks, and at first follow-ups.
measure: Use of systemic corticosteroids
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Level of respiratory support
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Number of participants requiring pleural drainage
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Duration of pleural drainage
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Number of participants in whom intrapleural fibrinolytics were administered
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Number of participants in whom surgical treatment was performed
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Number of patients with complications
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Number of patients with fatal outcome of the disease
timeFrame: from hospital admission to discharge, lasting on average from one to three weeks.
measure: Radiological resolution on follow-ups
timeFrame: Follow-ups at 3, 6 and 12 months after discharge if available.
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: IMotherChildHealth
Study officials:
References: