Managing Bacterial Pneumonia in Children Without Antimicrobials

NCT03256474 | Completed

• 1 other identifier: PKA_01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (6)

• 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

• Medical complication rate

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

  Between admission and 3 months after discharge

• 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

• Readmission rate

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

  7 - 10 years after hospitalization

• 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

• 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 Outcomes (11)

• Changes in respiratory rate

  Between admission and 3 months after discharge

• Changes in Bacterial Pneumonia Score

  Between admission and 3 months after discharge

• Changes in oxygen saturation

  Between admission and 3 months after discharge

• Changes in CRP

  Between admission and 3 months after discharge

• Changes in leukocyte count

  Between admission and 3 months after discharge

Interventions

Multimodal Therapy OTHER

Drugs, external applications like chest wraps, inhalations

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: August 22, 2017
• Study Start: October 15, 2017
• Primary Completion: November 30, 2017
• Study Completion: February 25, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

DE (1)