Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia

Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04681339
Collaborator
Gemeinschaftskrankenhaus Herdecke, Germany (Other)
200
2
27
100
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia: a Prospective, Observational Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever [During hospitalization, an average of 7 days]

    Rates of treatment with and without antibiotics during hospitalization

Secondary Outcome Measures

  1. Number of medical complications [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 [During hospitalization, an average of 7 days]

    Physician questionnaire (closed-ended questions)

  3. Parental satisfaction [At discharge, assessing the entire duration of the hospital stay, an average of 7 days]

    Parental satisfaction questionnaire (closed-ended questions)

  4. Hospitalization duration [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 [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 [During hospitalization, an average of 7 days]

    Oxygen therapy for O2 saturation <92%

  7. Use of antipyretic medications [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 [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 [4 weeks after end of hospitalization]

    New hospital admission for pneumonia; treatment requiring recurrence of pneumonia

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Die Filderklinik Filderstadt Baden-Württemberg Germany 70794
2 Herdecke Community Hospital Herdecke Nordrhein-Westfalen Germany 58313

Sponsors and Collaborators

  • ARCIM Institute Academic Research in Complementary and Integrative Medicine
  • Gemeinschaftskrankenhaus Herdecke, Germany

Investigators

  • Principal Investigator: Jan Vagedes, Dr, Arcim Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier:
NCT04681339
Other Study ID Numbers:
  • PKA-03
First Posted:
Dec 23, 2020
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022