Complicated Pneumonia (CP) in Children in South-East Europe
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAleksandar Sovtic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
The values will be expressed as percentage. Incidence rates will be calculated for each year and across different centers.
Time frame
January 1st 2014 to April 30th 2024Secondary outcomes
1
Distribution of different types of complicated community acquired pneumonia
The value will be collected as categorical variable (different category for each type: pleural effusion, necrotizing pneumonia, lung abscess). It will be expressed as percentage of total number of participants. Statistical analysis will be conducted in order to determine which types are related to longer hospitalization, ICU admission, more severe clinical course, fatal outcome, incomplete radiological resolution on follow ups and complications.
Time frame
from hospital admission to discharge, lasting on average from one to three weeks.2
Number of participants vaccinated against Streptococcus pneumoniae with pneumococcal conjugate vaccine and distribution of vaccines covering for different number of serotypes
The value will be collected as categorical variable (categories for vaccinated and non-vaccinated). It will be expressed as percentage of total number of participants. Statistical analysis will be conducted in order to determine if non-vaccinated participants had longer hospitalization, ICU admission, more severe clinical course, fatal outcome, incomplete radiological resolution on follow ups and complications.
Time frame
from hospital admission to discharge, lasting on average from one to three weeks.3
Distribution of different Streptococcus pneumoniae vaccines covering for different number of serotypes
The value will be collected as categorical variable (category for vaccines covering for different number of serotypes). It will be expressed as percentage of total number of participants vaccinated. Statistical analysis will be conducted in order to determine relation of vaccines covering for different serotypes with different Streptococcus pneumoniae serotype distribution, hospitalization length, ICU admission, more severe clinical course, fatal outcome, incomplete radiological resolution on follow ups and complications.
Time frame
from hospital admission to discharge, lasting on average from one to three weeks.4
Duration of symptoms before hospitalization
The value will be expressed as continuous variable (number of days). The duration of symptoms before hospitalization will be analyzed using descriptive statistics, reported as a mean (± standard deviation) and median (with interquartile range). Regression analysis may be used to identify factors associated with longer symptom duration (e.g., age, vaccination status). Comparison between groups of participants with different types of complicated community-acquired pneumonia will be done.
Time frame
recorded at the time of hospital admission.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aleksandar Sovtic
Lead sponsor
Mother and Child Health Institute of Serbia Dr Vukan Cupic
Sponsor institution
Source ClinicalTrials.gov