Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia

Antibiotic Stewardship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681339
• Other study ID #: PKA-03
• Status: Recruiting
• Start date: September 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: Jan Vagedes, Dr
• Phone: +49 711 7703
• Email: j.vagedes[@]arcim-institute.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Stewardship
• Community Acquired Pneumonia in Children
• Pneumonia

Intervention

Other:
• Antibiotic treatment
Antibiotic treatment
• No antibiotic treatment
No antibiotic treatment

Locations

Country	Name	City	State
Germany	Die Filderklinik	Filderstadt	Baden-Württemberg
Germany	Herdecke Community Hospital	Herdecke	Nordrhein-Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine	Gemeinschaftskrankenhaus Herdecke, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Factors in physician decision making on antibiotic prescription	Physician questionnaire (closed-ended questions)	During hospitalization, an average of 7 days
Secondary	Parental satisfaction	Parental satisfaction questionnaire (closed-ended questions)	At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Secondary	Hospitalization duration	Number of hospitalization days	At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Secondary	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
Secondary	Days of supplemental oxygen use	Oxygen therapy for O2 saturation <92%	During hospitalization, an average of 7 days
Secondary	Use of antipyretic medications	Number of doses of paracetamol or ibuprofen during hospitalization	During hospitalization, an average of 7 days
Secondary	Number of complementary medicine medications used per child	Number of complementary medication during hospitalization	During hospitalization, an average of 7 days
Secondary	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