Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia

Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia: a Prospective, Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Community Acquired Pneumonia in Children; Antibiotic Stewardship
• Intervention / Treatment: Other: Antibiotic treatment; Other: No antibiotic treatment

Detailed Description

An observational study to document the antibiotic treatment rate of children hospitalized for community acquired pneumonia at a pediatric department with longstanding practice of restrictive antibiotic prescribing. Patients will be enrolled consecutively and treated according to in-house standard operating procedure. Antibiotic treatment rate, severity of disease and medical complication rate in antibiotic and non-antibiotic managed children, frequency of predefined factors in physician decision making on antibiotic use, and parental satisfaction will be recorded. Parents will be contacted at least 4 weeks after discharge to inquire about recurrence or readmission.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jan Vagedes, Dr; Phone Number: 1688 +49 711 7703; Email: j.vagedes@arcim-institute.de

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Recruiting
      • Die Filderklinik
      • Contact: Jan Vagedes, MD, Dr; Phone Number: 1688 +49 711 7703; Email: j.vagedes@arcim-institute.de
  • Nordrhein-Westfalen
    • Herdecke, Nordrhein-Westfalen, Germany, 58313
      • Recruiting
      • Herdecke Community Hospital
      • Contact: Alfred Längler, Professor; Phone Number: +49 2330 622229; Email: a.laengler@gemeinschaftskrankenhaus.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children (aged 3 months to 18 years) who are hospitalized for pneumonia.

Description

Inclusion Criteria:

• 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
• All inclusion criteria have to be fulfilled

Exclusion Criteria:

• Insufficient knowledge of German to understand the written patient information and questionnaire

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pneumonia with antibiotics; Children with non-severe community acquired pneumonia and fever: managed with antibiotics	Other: Antibiotic treatment; Antibiotic treatment
Pneumonia without antibiotics; Children with non-severe community acquired pneumonia and fever: managed without antibiotics	Other: No antibiotic treatment; No antibiotic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of medical complications	Medical complications defined as a) admission to intensive care, mechanical ventilation, transfer to tertiary car center OR b) pleural effusion or empyema, pneumothorax, lung abscess, bronchopleural fistula, necrotizing pneumonia, acute respiratory failure, infectious complication (meningitis, septic shock).	During hospitalization, an average of 7 days
Factors in physician decision making on antibiotic prescription	Physician questionnaire (closed-ended questions)	During hospitalization, an average of 7 days
Parental satisfaction	Parental satisfaction questionnaire (closed-ended questions)	At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Hospitalization duration	Number of hospitalization days	At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Number of children with relevant comorbidity	Co-morbidities that may affect decision on antimicrobial use: a) chronic conditions (e.g. neurological conditions such as cerebral palsy, Down syndrome; or chronic respiratory conditions such as asthma, cystic fibrosis; or heart conditions). b) acute infectious comorbidities: bronchiolitis, otitis media, urinary tract infection, confirmed influenza virus or Respiratory Syncytial Virus or SARS-CoV2.	During hospitalization, an average of 7 days
Days of supplemental oxygen use	Oxygen therapy for O2 saturation <92%	During hospitalization, an average of 7 days
Use of antipyretic medications	Number of doses of paracetamol or ibuprofen during hospitalization	During hospitalization, an average of 7 days
Number of complementary medicine medications used per child	Number of complementary medication during hospitalization	During hospitalization, an average of 7 days
Number of readmissions for pneumonia or new pneumonia recurrences within 4 weeks of hospital discharge	New hospital admission for pneumonia; treatment requiring recurrence of pneumonia	4 weeks after end of hospitalization

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: Gemeinschaftskrankenhaus Herdecke, Germany
• Investigators: Principal Investigator: Jan Vagedes, Dr, Arcim Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pediatrics; Community acquired pneumonia; Antibiotic use; Hospitalised children; Integrative medicine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: PKA-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication
• IPD Sharing Time Frame: The data will be made available upon publication for a duration of three months.
• IPD Sharing 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 Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No