Antibiotic PrescriptionMOFICHENCT05221437
Management and Outcome of Fever in Children in Europe
An observational study of Antibiotic Prescription, run by Imperial College London.
Trial summary
This is an observational study assessing the management and outcome of children presenting to Emergency Departments (ED) with fever across Europe. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Antibiotic Prescription
- What is being tested?
- antibiotic prescription
- How many people
- 38,480 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Febrile children aged 0- 18 years visiting the emergency care.
Who may be able to join
- 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
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Antibiotic Prescription
- Being tested
- antibiotic prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic prescriptionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescription
number of antibiotic prescriptions
Measured: one year
hospitalization
number of children requiring admission to hospital
Measured: one year
Number of investigations
number of investigations
Measured: one year
Number of children re-attending within 5 days of the first hospital presentation.
Number of re-attendance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2017
- Primary completion1 Apr 2018
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic PrescriptionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221437
- Sponsor's protocol ID
- REC ref: 16/LO/1684-S
- Acronym
- MOFICHE
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)
- ClinicalTrials.gov ID
- NCT05221437
- Acronym / sponsor ID
- MOFICHE / REC ref: 16/LO/1684-S
- Conditions
- Antibiotic Prescription
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,480 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study assessing the management and outcome of children presenting to Emergency Departments (ED) with fever across Europe.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Febrile children aged 0- 18 years visiting the emergency care.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic prescription | Other | – |
Primary outcome
Antibiotic prescription
Time frame: one year
number of antibiotic prescriptions
hospitalization
Time frame: one year
number of children requiring admission to hospital
Number of investigations
Time frame: one year
number of investigations
Number of children re-attending within 5 days of the first hospital presentation.
Time frame: one year
Number of re-attendance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: No
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Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Prescription, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic prescription (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.