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Completed

NCT Number: NCT03256474

Managing Bacterial Pneumonia in Children Without Antimicrobials

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal Therapy

Other

Drugs, external applications like chest wraps, inhalations

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. Readmission rate

    Time frame: 7 - 10 years after hospitalization

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

  5. 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

  6. 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

Secondary outcomes

  1. Changes in respiratory rate

    Time frame: Between admission and 3 months after discharge

    Changes in respiratory rate as an indicator for pulmonary infection

  2. Changes in Bacterial Pneumonia Score

    Time frame: Between admission and 3 months after discharge

    Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection

  3. Changes in oxygen saturation

    Time frame: Between admission and 3 months after discharge

    Changes in oxygen saturation as an indicator for pulmonary infection

  4. Changes in CRP

    Time frame: Between admission and 3 months after discharge

    Changes in CRP as an indicator for infection

  5. Changes in leukocyte count

    Time frame: Between admission and 3 months after discharge

    Changes in leukocyte count as an indicator for infection

  6. Changes in pH

    Time frame: Between admission and 3 months after discharge

    Changes in pH as an indicator for respiratory distress

  7. Changes in pCO2

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Between admission and 3 months after discharge

    Number of patients treated with antipyretics

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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