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RecruitingNCT04681339Updated Sep 17, 2026

Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia

An observational study in Community Acquired Pneumonia in Children and Antibiotic Stewardship, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Recruiting at 2 sites in Germany. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
3 Months to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Community Acquired Pneumonia in Children
  • Antibiotic Stewardship

Keywords

  • Community acquired pneumonia
  • Antibiotic use
  • Pediatrics
  • Hospitalised children
  • Integrative medicine
03

Who can participate

Ages eligible
3 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Insufficient knowledge of German to understand the written patient information and questionnaire
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pneumonia with antibiotics

    Children with non-severe community acquired pneumonia and fever: managed with antibiotics

    Other: Antibiotic treatment

  • Pneumonia without antibiotics

    Children with non-severe community acquired pneumonia and fever: managed without antibiotics

    Other: No antibiotic treatment

Interventions

  • OtherAntibiotic treatment

    Antibiotic treatment

  • OtherNo antibiotic treatment

    No antibiotic treatment

05

What researchers measure

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

    Time frame: During hospitalization, an average of 7 days

Secondary outcomes

  1. 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).

    Time frame: During hospitalization, an average of 7 days

  2. Factors in physician decision making on antibiotic prescription

    Physician questionnaire (closed-ended questions)

    Time frame: During hospitalization, an average of 7 days

  3. Parental satisfaction

    Parental satisfaction questionnaire (closed-ended questions)

    Time frame: At discharge, assessing the entire duration of the hospital stay, an average of 7 days

  4. Hospitalization duration

    Number of hospitalization days

    Time frame: At discharge, assessing the entire duration of the hospital stay, an average of 7 days

  5. 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.

    Time frame: During hospitalization, an average of 7 days

  6. Days of supplemental oxygen use

    Oxygen therapy for O2 saturation \<92%

    Time frame: During hospitalization, an average of 7 days

  7. Use of antipyretic medications

    Number of doses of paracetamol or ibuprofen during hospitalization

    Time frame: During hospitalization, an average of 7 days

  8. Number of complementary medicine medications used per child

    Number of complementary medication during hospitalization

    Time frame: During hospitalization, an average of 7 days

  9. 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

    Time frame: 4 weeks after end of hospitalization

06

Study locations

2 of 2 sites recruiting
  • Die Filderklinik
    Filderstadt, Baden-Wurttemberg 70794, Germany
    Recruiting
  • Herdecke Community Hospital
    Herdecke, North Rhine-Westphalia 58313, Germany
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — IPD that underlie results in a publication

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04681339
Lead sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators
Gemeinschaftskrankenhaus Herdecke, Germany
Responsible party
Sponsor
First posted
Dec 23, 2020
Start date
Sep 16, 2022
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Jan Vagedes, Dr
Contact
j.vagedes@arcim-institute.de
+49 711 7703 ext. 1688
Jan Vagedes, Dr
principal investigator · Arcim Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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