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CompletedNCT03256474Updated Feb 17, 2020

Managing Bacterial Pneumonia in Children Without Antimicrobials

An observational study in Pneumonia, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
350
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pneumonia
03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • None
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
350 participants (actual)
Patient registry
No

Interventions

  • OtherMultimodal Therapy

    Drugs, external applications like chest wraps, inhalations

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Between admission and 3 months after discharge

  2. Medical complication rate

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

    Time frame: Between admission and 3 months after discharge

  3. Length of hospital stay

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

    Time frame: Between admission and 3 months after discharge

  4. Readmission rate

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

    Time frame: 7 - 10 years after hospitalization

  5. Temperature normalization

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

    Time frame: Between admission and 3 months after discharge

  6. Days of supplemental oxygen need

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

    Time frame: Between admission and 3 months after discharge

Secondary outcomes

  1. Changes in respiratory rate

    Changes in respiratory rate as an indicator for pulmonary infection

    Time frame: Between admission and 3 months after discharge

  2. Changes in Bacterial Pneumonia Score

    Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection

    Time frame: Between admission and 3 months after discharge

  3. Changes in oxygen saturation

    Changes in oxygen saturation as an indicator for pulmonary infection

    Time frame: Between admission and 3 months after discharge

  4. Changes in CRP

    Changes in CRP as an indicator for infection

    Time frame: Between admission and 3 months after discharge

  5. Changes in leukocyte count

    Changes in leukocyte count as an indicator for infection

    Time frame: Between admission and 3 months after discharge

  6. Changes in pH

    Changes in pH as an indicator for respiratory distress

    Time frame: Between admission and 3 months after discharge

  7. Changes in pCO2

    Changes in pCO2 as an indicator for respiratory distress

    Time frame: Between admission and 3 months after discharge

  8. 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

    Time frame: Day of admission

  9. 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

    Time frame: Between admission and 3 months after discharge

  10. Antimicrobial treatment rate in children with viral pneumonia

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

    Time frame: Between admission and 3 months after discharge

  11. Number of patients treated with antipyretics

    Number of patients treated with antipyretics

    Time frame: Between admission and 3 months after discharge

06

Study locations

1 site
  • Arcim Institute
    Filderstadt, Baden-Württemberg 70794, Germany
07

Registry details

Key details

Study ID
NCT03256474
Lead sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Oct 15, 2017
Primary completion
Nov 30, 2017
Completion
Feb 25, 2018
Last update
Feb 17, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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