Complicated Pneumonia (CP) in Children in South-East Europe

NCT ID: NCT06657898

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-27
• Study Completion Date: 2025-10-01

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.

Conditions

Pneumonia, Necrotizing; Lung Abscess; Empyema, Pleural

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aleksandar Sovtic

OTHER

Sponsor Role: lead

Responsible Party

Aleksandar Sovtic

Ass.Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IMotherChildHealth

Belgrade, , Serbia

Site Status: RECRUITING

Countries

Serbia

Central Contacts

Aleksandar Sovtic, M.D. Ph.D

Role: CONTACT

aleksandar.sovtic@imd.org.rs

+381113108158

Tijana Grba, M.D.

Role: CONTACT

tijana.grba@imd.org.rs

+381113108158

Facility Contacts

Aleksandar Sovtic, M.D.Ph.D

Role: primary

aleksandar.sovtic@imd.org.rs

+381113108158

Tijana Grba, M.D.

Role: backup

tijana.grba@imd.org.rs

+381113108158

Other Identifiers

CP-SEE-2024

Identifier Type: -

Identifier Source: org_study_id