Clinical trial NCT04681339: Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia
Official title: Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia: a Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Community Acquired Pneumonia in Children
Antibiotic Stewardship
Keywords: Community acquired pneumonia
Antibiotic use
Pediatrics
Hospitalised children
Integrative medicine
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Gemeinschaftskrankenhaus Herdecke, Germany
First posted: 2020-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (aged 3 months to 18 years) who are hospitalized for pneumonia.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever
timeFrame: During hospitalization, an average of 7 days
Secondary outcomes:
measure: Number of medical complications
timeFrame: During hospitalization, an average of 7 days
measure: Factors in physician decision making on antibiotic prescription
timeFrame: During hospitalization, an average of 7 days
measure: Parental satisfaction
timeFrame: At discharge, assessing the entire duration of the hospital stay, an average of 7 days
measure: Hospitalization duration
timeFrame: At discharge, assessing the entire duration of the hospital stay, an average of 7 days
measure: Number of children with relevant comorbidity
timeFrame: During hospitalization, an average of 7 days
measure: Days of supplemental oxygen use
timeFrame: During hospitalization, an average of 7 days
measure: Use of antipyretic medications
timeFrame: During hospitalization, an average of 7 days
measure: Number of complementary medicine medications used per child
timeFrame: During hospitalization, an average of 7 days
measure: Number of readmissions for pneumonia or new pneumonia recurrences within 4 weeks of hospital discharge
timeFrame: 4 weeks after end of hospitalization
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Die Filderklinik
state: Baden-Württemberg
city: Herdecke
country: Germany
facility: Herdecke Community Hospital
state: Nordrhein-Westfalen
Study officials:
affiliation: Arcim Institute
name: Jan Vagedes, Dr
role: PRINCIPAL_INVESTIGATOR
References: