FeverFEVERNCT07344090
Using a Decision-making System to Support the Management of Fever and Acute Pain in Children
A study testing Puntofarma® FEVER in people with Fever and Acute Pain, run by Qwince Innovation S.r.l. at 1 site in Italy.
Trial summary
FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a Class I Medical Device (Puntofarma®), which is made available through a downloadable mobile phone app, can, given specific input, improve the appropriateness and… Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Fever, Acute Pain
- What is being tested?
- Puntofarma® FEVER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 28 Dec 2025to 30 May 2026
- Phase
- Interventional
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have a fever and are prescribed paracetamol, or who have already received a prescription for an antipyretic from an outside physician before accessing the emergency room.
- Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have acute pain and are prescribed paracetamol, or who have already received a prescription for an analgesic from an outside physician before accessing the emergency room.
- Pediatric patients whose caregivers have knowledge of the Italian language.
- Pediatric patients whose caregivers have access to the internet and have a smartphone that is either the latest generation or no older than five years.
Who cannot join
- Pediatric patients, male or female, aged less than 3 months and over 5 years.
- Pediatric patients who have experienced adverse reactions or contraindications to paracetamol administration.
- Pediatric patients whose caregivers have little or no knowledge of the Italian language.
- Pediatric patients whose caregivers do not have internet access or do not have a latest-generation smartphone or, in any case, one no older than five years.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Meyer University Children's Hospital Florence
Florence, Italy, 50139
About this study
Official title: Premarket Investigation on the Use of a Digital Decision-making Aid Aimed at Improving the Appropriateness and Adherence to Therapy for the Management of Fever and Acute Pain in Patients Between 3 Months and 1 Day and 5 Years of Age
FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a Class I Medical Device (Puntofarma®), which is made available through a downloadable mobile phone app, can, given specific input, improve the appropriateness and adherence to therapy for the management of fever and pain in children between 3 months and 1 day and 5 years of age.
100 patients are expected to be enrolled, equally distributed between febrile patients (50%) and patients with acute pain (50%). Patients admitted to the Regional Pediatric Emergency Department of the Meyer IRCCS Hospital in the presence of a feverish episode and/or acute pain will be enrolled upon discharge.
The study will last a total of 8 months (Jan - Aug 2026), with enrollment expected by Jan 2026. Each patient will be involved in the study for a maximum of 7 days from enrollment, during which they will use the mobile app. Participation in the study will conclude by the seventh day of use of the app, with the completion of a satisfaction questionnaire.
Read the detailed description
FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a medical device (Puntofarma®), given specific input, can improve the appropriateness and adherence to pharmacological therapy with paracetamol for the management of fever and acute pain in patients between 3 months and 1 day and 5 years of age. The algorithm for digital pharmacological support was developed based on therapeutic guidelines.
The study lasts seven days from the date of enrollment of the individual patient.
Upon admission to the emergency room for an episode of fever and/or acute pain, provided that all eligibility criteria are met, and following receipt of signed informed consent, the investigator will propose the study to the patient's family members or caregivers. The patient will be managed according to clinical standards regarding the presenting condition. Participation in the study, or refusal, will not result in any changes to the flow or management of the patient as required by the current clinical condition or current standards.The study will begin immediately upon the patient's discharge from the emergency room.
After signing the informed consent form, the patient and caregiver will be enrolled in the study and registered in the Puntofarma® system, resulting in the issuance of a unique code.
No personal data of the patient and/or caregiver will be recorded on the device. At the same time, each enrolled patient will be issued a PIN code through which the caregiver will be able to register in the digital application and begin using the algorithm from their mobile/digital device. Caregivers will be asked to enter the information in the application necessary for the algorithm to calculate the recommended dose of paracetamol. The application, which can be downloaded to a mobile phone, is used to verify adherence to the antipyretic therapy suggested by the algorithm, which is based on the guidelines for the management of fever and acute pain in children.
No follow-up visits, tests, or additional services are scheduled during the seven-day investigation. Seven days after patient enrollment, at the conclusion of the study, the parent/caregiver will be given a questionnaire (also via the app) to assess the usability and caregiver satisfaction with the use of the app.
The app includes an optional diary, relating to fever, pain, or other symptoms/events, in which it is also possible to record additional information and to report adverse events or device defects.
- Conditions
- Fever, Acute Pain
- Being tested
- Puntofarma® FEVER
- Keywords
- fever, acute pain, pediatrics
- Medical subject headings
- Fever, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puntofarma® FEVERDevice
Puntofarma® is a software-based medical device, which the manufacturer intends to use in standalone mode, with the aim of improving prevention, monitoring, and patient care processes.
In the context of the FEVER clinical trial, it is designed to:
- acquire and organize pediatric patient health information (measurements, parameters);
- assist caregivers/parents in managing fever/acute pain, including through alarms and reminders;
- create a communication channel between caregivers/parents and healthcare professionals.
The clinically relevant features of Puntofarma® for the FEVER study are as follows:
- collect data regarding the patient's health and treatment status;
- enable the collection of data relating to episodes of fever and/or acute pain (Fever Diary, Pain Diary, and Other Events/Symptoms Diary);
- manage the Fever Diary and Pain Diary, therapy planning, and therapeutic reconnaissance (for appropriateness purposes).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | After signing the informed consent, the patient and caregiver will be enrolled in the study and registered in the Puntofarma® system, resulting in the issuance of a unique code. No personal data of the patient and/or caregiver will be recorded on the device.
At the same time, a PIN code will be issued for each enrolled patient, allowing the caregiver to register in the digital application and begin using the algorithm from their mobile/digital device.
Caregivers will be required to enter the necessary information into the application so that the algorithm can calculate the recommended dose of paracetamol. The application, which can be downloaded to a mobile phone, is used to verify adherence to the antipyretic therapy suggested by the algorithm and based on the guidelines for the management of fever and acute pain in children. Receives: Device: Puntofarma® FEVER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of adherence to the prescribed dosage of paracetamol during the treatment cycle.
Measurement of adherence to the prescribed dosage of paracetamol during the treatment cycle.
Measured: 8 days of treatment
Secondary outcomes (4)
Evaluation of the consistency of the timing of paracetamol administration during the treatment period
Evaluation of the consistency of the timing of paracetamol administration during the treatment period
Measured: 8 days of intervention
Digital app usage rate: Percentage of parents/caregivers using the digital app
Digital app usage rate:
Percentage of parents/caregivers using the digital app
Measured: 8 days of intervention
Number (%) of patients taking ibuprofen
Number (%) of patients taking ibuprofen
Measured: 8 days of intervention
Caregiver satisfaction
Satisfaction level using a rating scale. Caregiver satisfaction:
Measured using a structured questionnaire/Likert scale to evaluate the user experience and perceived usefulness of the application
Measured: 8 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start28 Dec 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Why it stopped: Failure to reach the target sample size
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qwince Innovation S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Consorzio per Valutazioni Biologiche e Farmacologiche
- Responsible party
- Sponsor
- Investigators
- Niccolò Parri, MD, Pediatric Emergency, Principal investigator, Meyer University Children's Hospital Florence, Department of Emergency Medicine and Trauma Center, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344090
- Sponsor's protocol ID
- ID-CE-29153
- Other IDs
- EUDAMED Number 25-10-054835
- Acronym
- FEVER
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Under review by the Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premarket Investigation on the Use of a Digital Decision-making Aid Aimed at Improving the Appropriateness and Adherence to Therapy for the Management of Fever and Acute Pain in Patients Between 3 Months and 1 Day and 5 Years of Age
- ClinicalTrials.gov ID
- NCT07344090
- Acronym / sponsor ID
- FEVER / ID-CE-29153
- Conditions
- Fever, Acute Pain
- Keywords
- fever, acute pain, pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to reach the target sample size
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Qwince Innovation S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Consorzio per Valutazioni Biologiche e Farmacologiche
- Study start
- 28 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 15 Jan 2026 (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 is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a Class I Medical Device (Puntofarma®), which is made available through a downloadable mobile phone app, can, given specific input, improve the appropriateness and adherence to therapy for the management of fever and pain in children between 3 months and 1 day and 5 years of age.
100 patients are expected to be enrolled, equally distributed between febrile patients (50%) and patients with acute pain (50%). Patients admitted to the Regional Pediatric Emergency Department of the Meyer IRCCS Hospital in the presence of a feverish episode and/or acute pain will be enrolled upon discharge.
The study will last a total of 8 months (Jan - Aug 2026), with enrollment expected by Jan 2026. Each patient will be involved in the study for a maximum of 7 days from enrollment, during which they will use the mobile app. Participation in the study will conclude by the seventh day of use of the app, with the completion of a satisfaction questionnaire.
Detailed description
FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a medical device (Puntofarma®), given specific input, can improve the appropriateness and adherence to pharmacological therapy with paracetamol for the management of fever and acute pain in patients between 3 months and 1 day and 5 years of age. The algorithm for digital pharmacological support was developed based on therapeutic guidelines.
The study lasts seven days from the date of enrollment of the individual patient.
Upon admission to the emergency room for an episode of fever and/or acute pain, provided that all eligibility criteria are met, and following receipt of signed informed consent, the investigator will propose the study to the patient's family members or caregivers. The patient will be managed according to clinical standards regarding the presenting condition. Participation in the study, or refusal, will not result in any changes to the flow or management of the patient as required by the current clinical condition or current standards.The study will begin immediately upon the patient's discharge from the emergency room.
After signing the informed consent form, the patient and caregiver will be enrolled in the study and registered in the Puntofarma® system, resulting in the issuance of a unique code.
No personal data of the patient and/or caregiver will be recorded on the device. At the same time, each enrolled patient will be issued a PIN code through which the caregiver will be able to register in the digital application and begin using the algorithm from their mobile/digital device. Caregivers will be asked to enter the information in the application necessary for the algorithm to calculate the recommended dose of paracetamol. The application, which can be downloaded to a mobile phone, is used to verify adherence to the antipyretic therapy suggested by the algorithm, which is based on the guidelines for the management of fever and acute pain in children.
No follow-up visits, tests, or additional services are scheduled during the seven-day investigation. Seven days after patient enrollment, at the conclusion of the study, the parent/caregiver will be given a questionnaire (also via the app) to assess the usability and caregiver satisfaction with the use of the app.
The app includes an optional diary, relating to fever, pain, or other symptoms/events, in which it is also possible to record additional information and to report adverse events or device defects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Puntofarma® FEVERAfter signing the informed consent, the patient and caregiver will be enrolled in the study and registered in the Puntofarma® system, resulting in the issuance of a unique code. No personal data of the patient and/or caregiver will be recorded on the device. At the same time, a PIN code will be issued for each enrolled patient, allowing the caregiver to register in the digital application and begin using the algorithm from their mobile/digital device. Caregivers will be required to enter the necessary information into the application so that the algorithm can calculate the recommended dose of paracetamol. The application, which can be downloaded to a mobile phone, is used to verify adherence to the antipyretic therapy suggested by the algorithm and based on the guidelines for the management of fever and acute pain in children. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have a fever and are prescribed paracetamol, or who have already received a prescription for an antipyretic from an outside physician before accessing the emergency room.
- Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have acute pain and are prescribed paracetamol, or who have already received a prescription for an analgesic from an outside physician before accessing the emergency room.
- Pediatric patients whose caregivers have knowledge of the Italian language.
- Pediatric patients whose caregivers have access to the internet and have a smartphone that is either the latest generation or no older than five years.
Key exclusion criteria (4 listed)
- Pediatric patients, male or female, aged less than 3 months and over 5 years.
- Pediatric patients who have experienced adverse reactions or contraindications to paracetamol administration.
- Pediatric patients whose caregivers have little or no knowledge of the Italian language.
- Pediatric patients whose caregivers do not have internet access or do not have a latest-generation smartphone or, in any case, one no older than five years.
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 |
|---|---|---|
| Puntofarma® FEVERPuntofarma® is a software-based medical device, which the manufacturer intends to use in standalone mode, with the aim of improving prevention, monitoring, and patient care processes. In the context of the FEVER clinical trial, it is designed to: * acquire and organize pediatric patient health information (measurements, parameters); * assist caregivers/parents in managing fever/acute pain, including through alarms and reminders; * create a communication channel between caregivers/parents and healthcare professionals. The clinically relevant features of Puntofarma® for the FEVER study are as follows: * collect data regarding the patient's health and treatment status; * enable the collection of data relating to episodes of fever and/or acute pain (Fever Diary, Pain Diary, and Other Events/Symptoms Diary); * manage the Fever Diary and Pain Diary, therapy planning, and therapeutic reconnaissance (for appropriateness purposes). | Device | Intervention arm |
Primary outcome
Measurement of adherence to the prescribed dosage of paracetamol during the treatment cycle.
Time frame: 8 days of treatment
Measurement of adherence to the prescribed dosage of paracetamol during the treatment cycle.
4 secondary outcomes
Evaluation of the consistency of the timing of paracetamol administration during the treatment period
Time frame: 8 days of intervention
Digital app usage rate: Percentage of parents/caregivers using the digital app
Time frame: 8 days of intervention
Number (%) of patients taking ibuprofen
Time frame: 8 days of intervention
Caregiver satisfaction
Time frame: 8 days of intervention
Results and safety
The study was stopped early (reason given: Failure to reach the target sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. Under review by the Sponsor
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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.
Niccolò Parri, MD, Pediatric Emergency principal investigator
Meyer University Children's Hospital Florence, Department of Emergency Medicine and Trauma Center, ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puntofarma® FEVER in people with Fever and Acute Pain, run by Qwince Innovation S.r.l. 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Oct 2026. 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?
The study was stopped early (reason given: Failure to reach the target sample size). 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?
Measurement of adherence to the prescribed dosage of paracetamol during the treatment cycle. (time frame: 8 days of treatment). 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 13 Oct 2026.