Skip to content

Managing Bacterial Pneumonia in Children Without Antimicrobials

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03256474
Enrollment
350
Registered
2017-08-22
Start date
2017-10-15
Completion date
2018-02-25
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

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.

Interventions

Drugs, external applications like chest wraps, inhalations

Sponsors

ARCIM Institute Academic Research in Complementary and Integrative Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cure rate of non-antimicrobial management of bacterial pneumoniaBetween admission and 3 months after dischargeCure 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.
Medical complication rateBetween admission and 3 months after dischargeMedical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
Length of hospital stayBetween admission and 3 months after dischargeLength of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials
Readmission rate7 - 10 years after hospitalizationReadmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials
Temperature normalizationBetween admission and 3 months after dischargeDays to temperature normalization (\< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials
Days of supplemental oxygen needBetween admission and 3 months after dischargeDays of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials

Secondary

MeasureTime frameDescription
Changes in pHBetween admission and 3 months after dischargeChanges in pH as an indicator for respiratory distress
Changes in pCO2Between admission and 3 months after dischargeChanges in pCO2 as an indicator for respiratory distress
Number of patients treated with antipyreticsBetween admission and 3 months after dischargeNumber of patients treated with antipyretics
Utilization rate of a package of complementary treatment measuresBetween admission and 3 months after dischargeUtilization 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
Antimicrobial treatment rate in children with viral pneumoniaBetween admission and 3 months after dischargeAntimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score
Rate of chronic and acute-infectious co-morbiditiesDay of admissionRate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials
Changes in respiratory rateBetween admission and 3 months after dischargeChanges in respiratory rate as an indicator for pulmonary infection
Changes in Bacterial Pneumonia ScoreBetween admission and 3 months after dischargeChanges in Bacterial Pneumonia Score as an indicator for pulmonary infection
Changes in oxygen saturationBetween admission and 3 months after dischargeChanges in oxygen saturation as an indicator for pulmonary infection
Changes in CRPBetween admission and 3 months after dischargeChanges in CRP as an indicator for infection
Changes in leukocyte countBetween admission and 3 months after dischargeChanges in leukocyte count as an indicator for infection

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026