An interventional study of Puntofarma® FEVER in Fever and Acute Pain, sponsored by Qwince Innovation S.r.l.. Terminated at 1 site in Italy. Open to participants aged 3 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Qwince Innovation S.r.l. · Not applicable, Interventional, and Other
Failure to reach the target sample size
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.
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.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's enrollment of 100 is below the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →This is the only study on the registry with Qwince Innovation S.r.l. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Puntofarma® FEVER
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).
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.
Time frame: 8 days of treatment
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
Time frame: 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
Time frame: 8 days of intervention
Number (%) of patients taking ibuprofen
Number (%) of patients taking ibuprofen
Time frame: 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
Time frame: 8 days of intervention
Plan to share: Undecided — Under review by the Sponsor
No publications or documents are linked to this record.
Failure to reach the target sample size
Failure to reach the target sample size
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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