FeverNCT07106073
Fever In Palliative Care
An observational study of Fever and Palliative Care, run by Stefania Cheli at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the frequency and characteristics of fever in terminally ill adult patients admitted to the Infectious Diseases Hospice at Luigi Sacco Hospital in Milan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever, Palliative Care, Terminal Illness
- What is being tested?
- Collection of demographic, anthropometric and clinical data.
- How many people
- 145 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2025to 22 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the Hospice of Infectious Diseases at Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy. The study population includes adult terminally ill patients admitted for end-of-life care.
Who may be able to join
- Male and female patients;
- Age ≥ 18 years;
- Terminally ill patients with an estimated life expectancy between 24 hours and 3 months;
- Signed informed consent.
Who cannot join
- Patients under 18 years of age;
- Terminally ill patients with a life expectancy < 24 hours
- Non-terminal patients admitted for respite care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: La Febbre Nelle Cure Palliative
The goal of this observational study is to evaluate the frequency and characteristics of fever in terminally ill adult patients admitted to the Infectious Diseases Hospice at Luigi Sacco Hospital in Milan. The main questions it aims to answer are:
- How often does fever occur in terminally ill patients during hospice care?
- What are the typical features of fever in this population in terms of intensity, duration, possible causes, and treatment strategies?
- Is there any correlation between the occurrence of fever and patients' clinical characteristics, such as age, sex, BMI, comorbidities, and palliative prognostic scores (PPS and PPI)?
Read more
Participants will be adult patients (≥18 years) with a life expectancy of more than 24 hours and less than 3 months.
During their stay, the following data will be collected:
- Presence and characteristics of fever (temperature, duration, treatment, suspected cause)
- Clinical and demographic information (e.g., age, sex, BMI, comorbidities, performance status)
- Details on hospitalization (e.g., symptom burden, need for palliative sedation, outcome)
The study will enroll approximately 250 patients consecutively over a 48-week period. No additional procedures or treatments beyond standard clinical care will be required.
Read the detailed description
Fever is a common clinical finding in palliative care, but its prevalence, causes, and management in terminally ill patients remain poorly documented. Existing studies report highly variable frequencies of fever near the end of life, ranging from 3% to 24%, depending on the population and setting. In this context, understanding the patterns and implications of fever in hospice patients is critical to improve symptom management and guide clinical decision-making.
This prospective, non-profit, single-center cohort study aims to collect real-world data on the presence of fever in a terminal population admitted to the Infectious Diseases Hospice at Luigi Sacco Hospital in Milan. The study will prospectively collect clinical, demographic, and treatment-related variables over a continuous 48-week period, without any deviation from routine clinical practice. By examining associations with prognostic indices, comorbidities, and symptom burden, the study also seeks to clarify whether fever represents a relevant marker of disease trajectory or end-of-life decline.
Data will be analyzed in aggregated, de-identified form using both descriptive and inferential statistics. This study is expected to contribute to filling a knowledge gap in palliative care literature and may help develop evidence-based guidance for the diagnostic and therapeutic management of fever in hospice settings.
- Conditions
- Fever, Palliative Care, Terminal Illness
- Being tested
- Collection of demographic, anthropometric and clinical data.
- Keywords
- Fever, Palliative Care, Hospice Care, Terminally ill patients, Infectious Diseases Hospice
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of demographic, anthropometric and clinical data.Other
Data collected is:
- demographic data: age, sex;
- anthropometric data: weight, height, body mass index;
- clinical data:
- Palliative Performance Scale;
- Palliative Prognostic Index;
- comorbidities;
- therapy;
- presence of medical devices;
- presence of pressure injuries;
- time on waiting list;
- place of care;
- primary diagnosis;
- length of stay;
- symptom burden at admission (Edmonton Symptom Assessment System);
- onset of fever and its characteristics (duration, intensity, treatment, etiology);
- need for sedation (duration, refractory symptom(s));
- outcome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Fever in Terminally Ill Patients
Number of patients who develop at least one febrile episode (defined as body temperature >37.5°C) during their stay in the hospice.
Unit of Measure: Number of patients
Measured: 48 weeks
Secondary outcomes (1)
Intensity of Fever
Maximum temperature recorded during febrile episodes among patients who develop fever.
Unit of Measure: Degrees Celsius (°C)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start27 Mar 2025
- Primary completion27 Jun 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania Cheli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania Cheli, ASST Fatebenefratelli Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106073
- Sponsor's protocol ID
- La febbre
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheli S, Angeli E, Corli O, Dinegro S, Zambelli A, Carta T, Shazivari R, Smolikova M, Franceschi P, Mola F, Cruzeiro YS, Clementi E, Gori A. Fever in a palliative care setting: Clinical insights and implications from a prospective observational cohort study. Palliat Med. 2026 May 31:2692163261450759. doi: 10.1177/02692163261450759. Online ahead of print.
PubMed 42218619
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- La Febbre Nelle Cure Palliative
- ClinicalTrials.gov ID
- NCT07106073
- Acronym / sponsor ID
- La febbre
- Conditions
- Fever, Palliative Care, Terminal Illness
- Keywords
- Fever, Palliative Care, Hospice Care, Terminally ill patients, Infectious Diseases Hospice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Stefania CheliUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 6 Aug 2025 (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.
The goal of this observational study is to evaluate the frequency and characteristics of fever in terminally ill adult patients admitted to the Infectious Diseases Hospice at Luigi Sacco Hospital in Milan. The main questions it aims to answer are:
- How often does fever occur in terminally ill patients during hospice care?
- What are the typical features of fever in this population in terms of intensity, duration, possible causes, and treatment strategies?
- Is there any correlation between the occurrence of fever and patients' clinical characteristics, such as age, sex, BMI, comorbidities, and palliative prognostic scores (PPS and PPI)?
Participants will be adult patients (≥18 years) with a life expectancy of more than 24 hours and less than 3 months.
During their stay, the following data will be collected:
- Presence and characteristics of fever (temperature, duration, treatment, suspected cause)
- Clinical and demographic information (e.g., age, sex, BMI, comorbidities, performance status)
- Details on hospitalization (e.g., symptom burden, need for palliative sedation, outcome)
The study will enroll approximately 250 patients consecutively over a 48-week period. No additional procedures or treatments beyond standard clinical care will be required.
Detailed description
Fever is a common clinical finding in palliative care, but its prevalence, causes, and management in terminally ill patients remain poorly documented. Existing studies report highly variable frequencies of fever near the end of life, ranging from 3% to 24%, depending on the population and setting. In this context, understanding the patterns and implications of fever in hospice patients is critical to improve symptom management and guide clinical decision-making.
This prospective, non-profit, single-center cohort study aims to collect real-world data on the presence of fever in a terminal population admitted to the Infectious Diseases Hospice at Luigi Sacco Hospital in Milan. The study will prospectively collect clinical, demographic, and treatment-related variables over a continuous 48-week period, without any deviation from routine clinical practice. By examining associations with prognostic indices, comorbidities, and symptom burden, the study also seeks to clarify whether fever represents a relevant marker of disease trajectory or end-of-life decline.
Data will be analyzed in aggregated, de-identified form using both descriptive and inferential statistics. This study is expected to contribute to filling a knowledge gap in palliative care literature and may help develop evidence-based guidance for the diagnostic and therapeutic management of fever in hospice settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the Hospice of Infectious Diseases at Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy. The study population includes adult terminally ill patients admitted for end-of-life care.
Key inclusion criteria (4 listed)
- Male and female patients;
- Age ≥ 18 years;
- Terminally ill patients with an estimated life expectancy between 24 hours and 3 months;
- Signed informed consent.
Key exclusion criteria (3 listed)
- Patients under 18 years of age;
- Terminally ill patients with a life expectancy < 24 hours
- Non-terminal patients admitted for respite care.
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 |
|---|---|---|
| Collection of demographic, anthropometric and clinical data.Data collected is: * demographic data: age, sex; * anthropometric data: weight, height, body mass index; * clinical data: * Palliative Performance Scale; * Palliative Prognostic Index; * comorbidities; * therapy; * presence of medical devices; * presence of pressure injuries; * time on waiting list; * place of care; * primary diagnosis; * length of stay; * symptom burden at admission (Edmonton Symptom Assessment System); * onset of fever and its characteristics (duration, intensity, treatment, etiology); * need for sedation (duration, refractory symptom(s)); * outcome. | Other | – |
Primary outcome
Frequency of Fever in Terminally Ill Patients
Time frame: 48 weeks
Number of patients who develop at least one febrile episode (defined as body temperature >37.5°C) during their stay in the hospice. Unit of Measure: Number of patients
1 secondary outcome
Intensity of Fever
Time frame: 48 weeks
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 6 Aug 2025.
- Derived from this study: PubMed 42218619Cheli S, Angeli E, Corli O, Dinegro S, Zambelli A, Carta T, Shazivari R, Smolikova M, Franceschi P, Mola F, Cruzeiro YS, Clementi E, Gori A. Fever in a palliative care setting: Clinical insights and implications from a prospective observational cohort study. Palliat Med. 2026 May 31:2692163261450759. doi: 10.1177/02692163261450759. Online ahead of print.
- Individual participant dataSharing planned: No
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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 and Palliative Care, run by Stefania Cheli 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 3 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 6 Aug 2025. 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 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?
Frequency of Fever in Terminally Ill Patients (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07106073, which also lists 1 linked publication.
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 6 Aug 2025.