Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia
1 other identifier
observational
200
1 country
2
Brief Summary
A study to observe how often antibiotics are prescribed in children hospitalized for pneumonia and how doctors decide if a child needs antibiotics or not. Parent satisfaction will also be recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2020
CompletedFirst Posted
Study publicly available on registry
December 23, 2020
CompletedStudy Start
First participant enrolled
September 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 8, 2025
January 1, 2025
3.2 years
December 14, 2020
January 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever
Rates of treatment with and without antibiotics during hospitalization
During hospitalization, an average of 7 days
Secondary Outcomes (9)
Number of medical complications
During hospitalization, an average of 7 days
Factors in physician decision making on antibiotic prescription
During hospitalization, an average of 7 days
Parental satisfaction
At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Hospitalization duration
At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Number of children with relevant comorbidity
During hospitalization, an average of 7 days
- +4 more secondary outcomes
Study Arms (2)
Pneumonia with antibiotics
Children with non-severe community acquired pneumonia and fever: managed with antibiotics
Pneumonia without antibiotics
Children with non-severe community acquired pneumonia and fever: managed without antibiotics
Interventions
Eligibility Criteria
Children (aged 3 months to 18 years) who are hospitalized for pneumonia.
You may qualify if:
- Hospital admission at the pediatric department of the Filderklinik or at the pediatric department of the Herdecke Community Hospital
- Admission diagnosis pneumonia or pneumonia diagnosis within 48 hours of admission
- Written informed consent by care giver
You may not qualify if:
- Insufficient knowledge of German to understand the written patient information and questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Die Filderklinik
Filderstadt, Baden-Wurttemberg, 70794, Germany
Herdecke Community Hospital
Herdecke, North Rhine-Westphalia, 58313, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Vagedes, Dr
Arcim Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2020
First Posted
December 23, 2020
Study Start
September 16, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
January 8, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The data will be made available upon publication for a duration of three months.
- Access Criteria
- The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
IPD that underlie results in a publication