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

NCT06657898 | Recruiting

• 1 other identifier: CP-SEE-2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Necrotizing; Lung Abscess; Empyema, Pleural

Keywords

pneumonia in children; necrotizing pneumonia; empyema; lung abscess

Outcome Measures

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.

  January 1st 2014 to April 30th 2024

Secondary Outcomes (27)

• 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.

• Duration of symptoms before hospitalization

  recorded at the time of hospital admission.

• Percutaneous oxygen saturation (SpO2)

  recorded at the time of hospital admission.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aleksandar Sovtic: lead

Study Sites (1)

IMotherChildHealth

Belgrade, Serbia

RECRUITING

MeSH Terms

Conditions

Pneumonia, Necrotizing; Lung Abscess; Empyema, Pleural; Empyema

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Abscess; Suppuration; Pleural Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aleksandar Sovtic, M.D. Ph.D

CONTACT

+381113108158; aleksandar.sovtic@imd.org.rs

Tijana Grba, M.D.

CONTACT

+381113108158; tijana.grba@imd.org.rs

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass.Prof.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 26, 2024
• Study Start: May 27, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)