MedPath

Managing Bacterial Pneumonia in Children Without Antimicrobials

Completed
Conditions
Pneumonia
Registration Number
NCT03256474
Lead Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Brief Summary

Retrospective cohort analysis of children hospitalized for pneumonia comparing disease severity on admission, clinical course, treatment and outcomes and prospective telephone based Follow-Up assessement.

Detailed Description

The investigators will conduct a retrospective cohort analysis of children hospitalized for pneumonia at the Filderklinik between December 2006 and November 2010. The Bacterial Pneumonia Score, a validated composite laboratory, clinical and radiologic score developed by Moreno et al, will be retrospectively applied to define cases as either viral or bacterial pneumonia. The investigators will compare disease severity on admission, clinical course, and outcomes (in terms of complications, length of stay and readmission rates) between antimicrobial and non-antimicrobial managed bacterial pneumonia cases. Long-term Follow-Up will be assessed by telephone interviews with the parents.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
350
Inclusion Criteria
  • Hospital admission at the pediatric department of the Filderklinik.
  • Admission diagnosis pneumonia (ICD J12.0, J12.1, J12.8, J12.9, J14, J15.1, J15.6, J15.7, J15.8, J15.9, J16.8, J18.0, J18.1, J18.8, J18.9 - all 12s, 15s, 16s, 18s)
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Readmission rate7 - 10 years after hospitalization

Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials

Days of supplemental oxygen needBetween admission and 3 months after discharge

Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials

Medical complication rateBetween admission and 3 months after discharge

Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials

Temperature normalizationBetween admission and 3 months after discharge

Days to temperature normalization (\< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials

Cure rate of non-antimicrobial management of bacterial pneumoniaBetween admission and 3 months after discharge

Cure rate of non-antimicrobial management of bacterial pneumonia (in the following and in the final publication, the term "bacterial pneumonia" will be used for children who fulfill the Moreno criteria for pneumonia): % of children managed without antimicrobials since admission, without subsequent need for antimicrobials or readmission.

Length of hospital stayBetween admission and 3 months after discharge

Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials

Secondary Outcome Measures
NameTimeMethod
Changes in oxygen saturationBetween admission and 3 months after discharge

Changes in oxygen saturation as an indicator for pulmonary infection

Rate of chronic and acute-infectious co-morbiditiesDay of admission

Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials

Number of patients treated with antipyreticsBetween admission and 3 months after discharge

Number of patients treated with antipyretics

Changes in respiratory rateBetween admission and 3 months after discharge

Changes in respiratory rate as an indicator for pulmonary infection

Changes in pHBetween admission and 3 months after discharge

Changes in pH as an indicator for respiratory distress

Changes in Bacterial Pneumonia ScoreBetween admission and 3 months after discharge

Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection

Utilization rate of a package of complementary treatment measuresBetween admission and 3 months after discharge

Utilization rate of a package of complementary treatment measures from anthroposophic medicine (including oral medications, inhalation and external nursing applications) in children managed with or without antimicrobials

Changes in CRPBetween admission and 3 months after discharge

Changes in CRP as an indicator for infection

Changes in leukocyte countBetween admission and 3 months after discharge

Changes in leukocyte count as an indicator for infection

Changes in pCO2Between admission and 3 months after discharge

Changes in pCO2 as an indicator for respiratory distress

Antimicrobial treatment rate in children with viral pneumoniaBetween admission and 3 months after discharge

Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score

Trial Locations

Locations (1)

Arcim Institute

🇩🇪

Filderstadt, Baden-Württemberg, Germany

© Copyright 2025. All Rights Reserved by MedPath