Managing Bacterial Pneumonia in Children Without Antimicrobials

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256474
• Other study ID #: PKA_01
• Status: Completed
• Start date: October 15, 2017
• Est. completion date: February 25, 2018

Study information

• Verified date: February 2020
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 25, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial

Intervention

Other:
• Multimodal Therapy
Drugs, external applications like chest wraps, inhalations

Locations

Country	Name	City	State
Germany	Arcim Institute	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Medical complication rate	Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials	Between admission and 3 months after discharge
Primary	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
Primary	Readmission rate	Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials	7 - 10 years after hospitalization
Primary	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
Primary	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	Changes in respiratory rate	Changes in respiratory rate as an indicator for pulmonary infection	Between admission and 3 months after discharge
Secondary	Changes in Bacterial Pneumonia Score	Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection	Between admission and 3 months after discharge
Secondary	Changes in oxygen saturation	Changes in oxygen saturation as an indicator for pulmonary infection	Between admission and 3 months after discharge
Secondary	Changes in CRP	Changes in CRP as an indicator for infection	Between admission and 3 months after discharge
Secondary	Changes in leukocyte count	Changes in leukocyte count as an indicator for infection	Between admission and 3 months after discharge
Secondary	Changes in pH	Changes in pH as an indicator for respiratory distress	Between admission and 3 months after discharge
Secondary	Changes in pCO2	Changes in pCO2 as an indicator for respiratory distress	Between admission and 3 months after discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients treated with antipyretics	Number of patients treated with antipyretics	Between admission and 3 months after discharge