FeverFEVER_EDNCT06194383
Treatment of Hyperpyrexia and in the Pediatric Emergency Department (FEVER_ED)
An observational study of Fever, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Fever represents the main cause of admission to the emergency room in older people pediatric. It occurs in the presence of a wide range of pathologies, from infectious forms (the most common, viral or bacterial) up to more complex and/or systemic forms (such as inflammatory or neoplastic ones). Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- Fever
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 22 Dec 2023to Dec 2024
- 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 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients (aged between 6 months 0 and 20 years), with fever (T \> 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)
Who may be able to join
- Pediatric patients (aged between 6 months 0 and 20 years)
- fever (T \> 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)
- who have expressed their consent to participate in the study.
Who cannot join
- age \<6 months or \>20 years;
- patients who did not express consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of the Treatment of Hyperpyrexia and Associated Symptoms in the Pediatric Emergency Department (FEVER_ED)
Fever represents the main cause of admission to the emergency room in older people pediatric. It occurs in the presence of a wide range of pathologies, from infectious forms (the most common, viral or bacterial) up to more complex and/or systemic forms (such as inflammatory or neoplastic ones). The drugs currently indicated for the management of fever in children are: paracetamol and ibuprofen. There are no recent studies conducted in pediatric population, who have demonstrated the greater effectiveness of therapy with paracetamol or ibuprofen, The objective of our study is, therefore, to identify which therapy is most appropriate for controlling body temperature e of associated symptoms in pediatric patients arriving in the emergency room with fever.
- Conditions
- Fever
- Medical subject headings
- Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to the treatment as evaluation of associated symptoms
Evaluation of associated symptoms by pain scale
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start22 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194383
- Sponsor's protocol ID
- ID6119
- Other IDs
- Fondazione Policlinico Univers
- Acronym
- FEVER_ED
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Treatment of Hyperpyrexia and Associated Symptoms in the Pediatric Emergency Department (FEVER_ED)
- ClinicalTrials.gov ID
- NCT06194383
- Acronym / sponsor ID
- FEVER_ED / ID6119
- Conditions
- Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
Fever represents the main cause of admission to the emergency room in older people pediatric. It occurs in the presence of a wide range of pathologies, from infectious forms (the most common, viral or bacterial) up to more complex and/or systemic forms (such as inflammatory or neoplastic ones). The drugs currently indicated for the management of fever in children are: paracetamol and ibuprofen. There are no recent studies conducted in pediatric population, who have demonstrated the greater effectiveness of therapy with paracetamol or ibuprofen, The objective of our study is, therefore, to identify which therapy is most appropriate for controlling body temperature e of associated symptoms in pediatric patients arriving in the emergency room with fever.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients (aged between 6 months 0 and 20 years), with fever (T \> 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)
Key inclusion criteria (3 listed)
- Pediatric patients (aged between 6 months 0 and 20 years)
- fever (T \> 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)
- who have expressed their consent to participate in the study.
Key exclusion criteria (2 listed)
- age \<6 months or \>20 years;
- patients who did not express consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response to the treatment as evaluation of associated symptoms
Time frame: 1 hour
Evaluation of associated symptoms by pain scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Response to the treatment as evaluation of associated symptoms (time frame: 1 hour). 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 8 Jan 2024.