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Clinical Trials/NCT03256474
NCT03256474
Completed
Not Applicable

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

ARCIM Institute Academic Research in Complementary and Integrative Medicine1 site in 1 country350 target enrollmentOctober 15, 2017
ConditionsPneumonia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Enrollment
350
Locations
1
Primary Endpoint
Readmission rate
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2017
End Date
February 25, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Readmission rate

Time Frame: 7 - 10 years after hospitalization

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

Days of supplemental oxygen need

Time Frame: Between admission and 3 months after discharge

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

Medical complication rate

Time Frame: Between admission and 3 months after discharge

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

Temperature normalization

Time Frame: Between 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 pneumonia

Time Frame: Between 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 stay

Time Frame: Between admission and 3 months after discharge

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

Secondary Outcomes

  • Changes in oxygen saturation(Between admission and 3 months after discharge)
  • Rate of chronic and acute-infectious co-morbidities(Day of admission)
  • Number of patients treated with antipyretics(Between admission and 3 months after discharge)
  • Changes in respiratory rate(Between admission and 3 months after discharge)
  • Changes in pH(Between admission and 3 months after discharge)
  • Changes in Bacterial Pneumonia Score(Between admission and 3 months after discharge)
  • Utilization rate of a package of complementary treatment measures(Between admission and 3 months after discharge)
  • Changes in CRP(Between admission and 3 months after discharge)
  • Changes in leukocyte count(Between admission and 3 months after discharge)
  • Changes in pCO2(Between admission and 3 months after discharge)
  • Antimicrobial treatment rate in children with viral pneumonia(Between admission and 3 months after discharge)

Study Sites (1)

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