- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05221437
Management and Outcome of Fever in Children in Europe (MOFICHE)
February 2, 2022 updated by: Imperial College London
Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)
This is an observational study assessing the management and outcome of children presenting to Emergency Departments (ED) with fever across Europe.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an observational study assessing the management and outcome of children presenting to Emergency Departments (ED) with fever across Europe.
This study will use large departmental datasets to collect information on at least 50,000 febrile episodes .
This study will use large-scale, pseudo-anonymized departmental data, and will not involve consented patient recruitment; nor will it use patient samples.
Data included in MOFICHE will be based on that collected as part of routine clinical care.
Antibiotic prescription, hospitalisation and number/type of investigations, re-attendance at ED within 5 days of the first hospital presentation will be recorded.
Study Type
Observational
Enrollment (Actual)
38480
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Febrile children aged 0- 18 years visiting the emergency care.
Description
Inclusion Criteria:
- aged 0- 18 years visiting the emergency care.
- fever measured at ED or history of (measured) fever less than 3 consecutive days prior to presentation at emergency department
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antibiotic prescription
Time Frame: one year
|
number of antibiotic prescriptions
|
one year
|
|
hospitalization
Time Frame: one year
|
number of children requiring admission to hospital
|
one year
|
|
Number of investigations
Time Frame: one year
|
number of investigations
|
one year
|
|
Number of children re-attending within 5 days of the first hospital presentation.
Time Frame: one year
|
Number of re-attendance
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
April 1, 2018
Study Completion (ACTUAL)
December 31, 2021
Study Registration Dates
First Submitted
January 18, 2022
First Submitted That Met QC Criteria
February 2, 2022
First Posted (ACTUAL)
February 3, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 3, 2022
Last Update Submitted That Met QC Criteria
February 2, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC ref: 16/LO/1684-S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.