NCT04681339

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 16, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.2 years

First QC Date

December 14, 2020

Last Update Submit

January 7, 2025

Conditions

Keywords

Community acquired pneumoniaAntibiotic usePediatricsHospitalised childrenIntegrative medicine

Outcome Measures

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

    During hospitalization, an average of 7 days

Secondary Outcomes (9)

  • Number of medical complications

    During hospitalization, an average of 7 days

  • Factors in physician decision making on antibiotic prescription

    During hospitalization, an average of 7 days

  • Parental satisfaction

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

  • Hospitalization duration

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

  • Number of children with relevant comorbidity

    During hospitalization, an average of 7 days

  • +4 more secondary outcomes

Study Arms (2)

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

Antibiotic treatment

Pneumonia with antibiotics

No antibiotic treatment

Pneumonia without antibiotics

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Die Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

RECRUITING

Herdecke Community Hospital

Herdecke, North Rhine-Westphalia, 58313, Germany

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Jan Vagedes, Dr

    Arcim Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 23, 2020

Study Start

September 16, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data will be made available upon publication for a duration of three months.
Access Criteria
The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Locations