Managing Bacterial Pneumonia in Children Without Antimicrobials

Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03256474
Collaborator
(none)
350
1
4.4
80.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis
Actual Study Start Date :
Oct 15, 2017
Actual Primary Completion Date :
Nov 30, 2017
Actual Study Completion Date :
Feb 25, 2018

Outcome Measures

Primary Outcome Measures

  1. Cure rate of non-antimicrobial management of bacterial pneumonia [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.

  2. Medical complication rate [Between admission and 3 months after discharge]

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

  3. Length of hospital stay [Between admission and 3 months after discharge]

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

  4. Readmission rate [7 - 10 years after hospitalization]

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

  5. Temperature normalization [Between admission and 3 months after discharge]

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

  6. Days of supplemental oxygen need [Between admission and 3 months after discharge]

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

Secondary Outcome Measures

  1. Changes in respiratory rate [Between admission and 3 months after discharge]

    Changes in respiratory rate as an indicator for pulmonary infection

  2. Changes in Bacterial Pneumonia Score [Between admission and 3 months after discharge]

    Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection

  3. Changes in oxygen saturation [Between admission and 3 months after discharge]

    Changes in oxygen saturation as an indicator for pulmonary infection

  4. Changes in CRP [Between admission and 3 months after discharge]

    Changes in CRP as an indicator for infection

  5. Changes in leukocyte count [Between admission and 3 months after discharge]

    Changes in leukocyte count as an indicator for infection

  6. Changes in pH [Between admission and 3 months after discharge]

    Changes in pH as an indicator for respiratory distress

  7. Changes in pCO2 [Between admission and 3 months after discharge]

    Changes in pCO2 as an indicator for respiratory distress

  8. Rate of chronic and acute-infectious co-morbidities [Day of admission]

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

  9. Utilization rate of a package of complementary treatment measures [Between 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

  10. Antimicrobial treatment rate in children with viral pneumonia [Between admission and 3 months after discharge]

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

  11. Number of patients treated with antipyretics [Between admission and 3 months after discharge]

    Number of patients treated with antipyretics

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arcim Institute Filderstadt Baden-Württemberg Germany 70794

Sponsors and Collaborators

  • ARCIM Institute Academic Research in Complementary and Integrative Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier:
NCT03256474
Other Study ID Numbers:
  • PKA_01
First Posted:
Aug 22, 2017
Last Update Posted:
Feb 17, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2020