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NCT Number: NCT04681339

Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia

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.

Recruiting

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Key information

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Die Filderklinik, Filderstadt, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antibiotic treatment

Other

Antibiotic treatment

No antibiotic treatment

Other

No antibiotic treatment

Primary outcomes

  1. Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever

    Time frame: During hospitalization, an average of 7 days

    Rates of treatment with and without antibiotics during hospitalization

Secondary outcomes

  1. Number of medical complications

    Time frame: During hospitalization, an average of 7 days

    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).

  2. Factors in physician decision making on antibiotic prescription

    Time frame: During hospitalization, an average of 7 days

    Physician questionnaire (closed-ended questions)

  3. Parental satisfaction

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

    Parental satisfaction questionnaire (closed-ended questions)

  4. Hospitalization duration

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

    Number of hospitalization days

  5. Number of children with relevant comorbidity

    Time frame: During hospitalization, an average of 7 days

    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.

  6. Days of supplemental oxygen use

    Time frame: During hospitalization, an average of 7 days

    Oxygen therapy for O2 saturation <92%

  7. Use of antipyretic medications

    Time frame: During hospitalization, an average of 7 days

    Number of doses of paracetamol or ibuprofen during hospitalization

  8. Number of complementary medicine medications used per child

    Time frame: During hospitalization, an average of 7 days

    Number of complementary medication during hospitalization

  9. Number of readmissions for pneumonia or new pneumonia recurrences within 4 weeks of hospital discharge

    Time frame: 4 weeks after end of hospitalization

    New hospital admission for pneumonia; treatment requiring recurrence of pneumonia

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Vagedes, Dr

CONTACT

[email protected]

+49 711 7703 ext. 1688

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • Gemeinschaftskrankenhaus Herdecke, Germany

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2020
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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