Managing Bacterial Pneumonia in Children Without Antimicrobials

Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Other: Multimodal Therapy

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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate of non-antimicrobial management of bacterial pneumonia	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.	Between admission and 3 months after discharge
Medical complication rate	Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials	Between admission and 3 months after discharge
Length of hospital stay	Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials	Between admission and 3 months after discharge
Readmission rate	Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials	7 - 10 years after hospitalization
Temperature normalization	Days to temperature normalization (< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials	Between admission and 3 months after discharge
Days of supplemental oxygen need	Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials	Between admission and 3 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in respiratory rate	Changes in respiratory rate as an indicator for pulmonary infection	Between admission and 3 months after discharge
Changes in Bacterial Pneumonia Score	Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection	Between admission and 3 months after discharge
Changes in oxygen saturation	Changes in oxygen saturation as an indicator for pulmonary infection	Between admission and 3 months after discharge
Changes in CRP	Changes in CRP as an indicator for infection	Between admission and 3 months after discharge
Changes in leukocyte count	Changes in leukocyte count as an indicator for infection	Between admission and 3 months after discharge
Changes in pH	Changes in pH as an indicator for respiratory distress	Between admission and 3 months after discharge
Changes in pCO2	Changes in pCO2 as an indicator for respiratory distress	Between admission and 3 months after discharge
Rate of chronic and acute-infectious co-morbidities	Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials	Day of admission
Utilization rate of a package of complementary treatment measures	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	Between admission and 3 months after discharge
Antimicrobial treatment rate in children with viral pneumonia	Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score	Between admission and 3 months after discharge
Number of patients treated with antipyretics	Number of patients treated with antipyretics	Between admission and 3 months after discharge

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): February 25, 2018

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial
• Other Study ID Numbers: PKA_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No