InfectionNCT06761118
NEWS2+Procalcitonin Association in Patients With Infection and Its Significance in Oncological Patients
An observational study of Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This observational study aims to evaluate the prognostic significance of the combination of a clinical score (specifically, a score obtained through the measurement of multiple parameters such as blood pressure, body temperature, etc., typically assessed during triage), called NEWS2, with certain laboratory tests in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 1,041 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the general Emergency Department for fever and/or other signs or symptoms of infection
Who may be able to join
- Patients presenting to the general Emergency Department of the IRCCS AOU of Bologna - S. Orsola Polyclinic for fever and/or other signs or symptoms of infection (for a period of 12 months following the date of study approval by the ethics committee and subsequent authorization by the General Director)
- Age ≥ 18 years - Obtaining informed consent (if possible, as specified in the protocol)
Who cannot join
- Patients with confirmed or suspected viral infections
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of the NEWS2 + Procalcitonin Association for Early Risk Stratification in Patients Presenting With Infection to the Emergency Department and Its Significance in Oncological Patients
This observational study aims to evaluate the prognostic significance of the combination of a clinical score (specifically, a score obtained through the measurement of multiple parameters such as blood pressure, body temperature, etc., typically assessed during triage), called NEWS2, with certain laboratory tests in patients presenting with a suspected infection to our Emergency Department. We decided to conduct this study because the presentation symptoms of an infection are varied and sometimes subtle, making it very difficult to immediately recognize an infection in patients arriving at the Emergency Department. It is even more challenging to identify those at higher risk for negative clinical outcomes. However, it has been shown that rapid identification and early, targeted therapy significantly improve prognosis, increasing the chances of patient recovery.
The study aims to identify a tool that can help physicians to early recognize patients with infection, particularly those at higher risk for an unfavorable course. To this end, we are evaluating the effectiveness of combining a clinical score, called NEWS2, with a laboratory parameter (procalcitonin).
Read more
It is anticipated that approximately 1,000-1,200 people will participate in this study over the course of one year.
The study plans to involve all patients presenting to the Emergency Department with a suspected infection. The diagnostic and therapeutic process will remain unchanged from the standard clinical practice applied according to international guidelines, and no follow-up assessments will be required in the subsequent months
Read the detailed description
In the literature, so far, for patients presenting to the Emergency Department with suspected infection, no clinical score for risk stratification has proven to be significantly superior to others, although NEWS2 seems to have the best performance. Additionally, no clinical study has evaluated the role of combining this score with procalcitonin. In the oncological subpopulation, the role of procalcitonin (PCT) is less investigated and more debated compared to the general population. This study aims to identify a valid tool for the early recognition of patients arriving at the Emergency Department with suspected infection who are at higher risk of negative clinical outcomes, both in the general population and in the oncological subpopulation.
During the Emergency Department visit, the NEWS2 clinical score will be calculated, and the patient will be treated according to the usual diagnostic and therapeutic protocol, which also includes procalcitonin measurement and SOFA score calculation (which, if ≥ 2, allows for the identification of sepsis, i.e., infection with organ damage). The correlation of the NEWS2 + procalcitonin association with in-hospital mortality, the percentage of admissions to intensive/sub-intensive care, and the length of hospital stay will then be assessed. These analyses will be conducted by subdividing the population based on the presence or absence of active neoplasm. Summary tables will report and describe the characteristics of the patients enrolled in the study for both the total cohort and the sub-cohorts (oncological and non-oncological patients).
Descriptive statistical analyses will be used to summarize the collected data: continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles; discrete or nominal variables will be reported using absolute frequencies and relative percentages. The distribution of continuous variables will be assessed through graphical visualization and the Kolmogorov-Smirnov correction test. Depending on the characteristics of the distribution, Chi-Square tests, Student's T-test, Mann-Whitney U test, and Wilcoxon tests will be used.
To address the primary objectives of the study, the following methodologies will be employed: the correlation between serum procalcitonin levels and NEWS2 will be examined using box plots. To assess whether procalcitonin may have independent incremental prognostic value from NEWS2 variables, a logistic regression model will be utilized. Procalcitonin values will be entered into the model as predefined ordinal scales to facilitate clinical application. We will then compare the predictive value of NEWS2 and NEWS2 + procalcitonin ordinal class. The predictive value of each model will first be calculated using the C-statistic or AUROC. Kaplan-Meier curves will also be used to evaluate the performance of procalcitonin and NEWS2.
To address the secondary objectives of the study, ROC analysis and Kaplan-Meier curves will be utilized. Data will be processed using IBM SPSS statistical software (version 28.0), and a p-value < 0.05 will be considered statistically significant.
- Conditions
- Infection
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Death during hospitalization
The percentage of patients who died during hospitalization, those admitted to intensive/sub-intensive care, and the length of hospital stay through the assessment of the prognostic significance of NEWS2 and the NEWS2 + PCT association in the entire population hospitalized for infection from the Emergency Department
Measured: through study completion, an average of 2 year
Died during hospitalization (oncological patients)
The percentage of patients who died during hospitalization, those admitted to intensive/sub-intensive care, and the length of hospital stay in the subpopulation of oncological patients through the evaluation of the role of PCT, the SOFA score, NEWS2, and the NEWS2 + PCT association in predicting the prognosis of oncological patients admitted for infection from the Emergency Department
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
Role of PCT as a predictive indicator of sepsis by SOFA score
Evaluate the role of PCT as a predictive indicator of sepsis (SOFA score ≥ 2) in oncological patients admitted from the Emergency Department for infection
Measured: through study completion, an average of 2 year
Presence of any differences in the prognostic significance of PCT (procalcitonin)
Assess the presence of any differences in the prognostic significance of PCT in the following subpopulations: patients with metastatic tumors versus those with non-metastatic tumors
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Feb 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 1,041 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonella Viola, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761118
- Sponsor's protocol ID
- PS-22-03
- Other IDs
- RC 22000499
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 7 Jan 2025
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the NEWS2 + Procalcitonin Association for Early Risk Stratification in Patients Presenting With Infection to the Emergency Department and Its Significance in Oncological Patients
- ClinicalTrials.gov ID
- NCT06761118
- Acronym / sponsor ID
- PS-22-03
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Jan 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.
This observational study aims to evaluate the prognostic significance of the combination of a clinical score (specifically, a score obtained through the measurement of multiple parameters such as blood pressure, body temperature, etc., typically assessed during triage), called NEWS2, with certain laboratory tests in patients presenting with a suspected infection to our Emergency Department. We decided to conduct this study because the presentation symptoms of an infection are varied and sometimes subtle, making it very difficult to immediately recognize an infection in patients arriving at the Emergency Department. It is even more challenging to identify those at higher risk for negative clinical outcomes. However, it has been shown that rapid identification and early, targeted therapy significantly improve prognosis, increasing the chances of patient recovery.
The study aims to identify a tool that can help physicians to early recognize patients with infection, particularly those at higher risk for an unfavorable course. To this end, we are evaluating the effectiveness of combining a clinical score, called NEWS2, with a laboratory parameter (procalcitonin).
It is anticipated that approximately 1,000-1,200 people will participate in this study over the course of one year.
The study plans to involve all patients presenting to the Emergency Department with a suspected infection. The diagnostic and therapeutic process will remain unchanged from the standard clinical practice applied according to international guidelines, and no follow-up assessments will be required in the subsequent months
Detailed description
In the literature, so far, for patients presenting to the Emergency Department with suspected infection, no clinical score for risk stratification has proven to be significantly superior to others, although NEWS2 seems to have the best performance. Additionally, no clinical study has evaluated the role of combining this score with procalcitonin. In the oncological subpopulation, the role of procalcitonin (PCT) is less investigated and more debated compared to the general population. This study aims to identify a valid tool for the early recognition of patients arriving at the Emergency Department with suspected infection who are at higher risk of negative clinical outcomes, both in the general population and in the oncological subpopulation.
During the Emergency Department visit, the NEWS2 clinical score will be calculated, and the patient will be treated according to the usual diagnostic and therapeutic protocol, which also includes procalcitonin measurement and SOFA score calculation (which, if ≥ 2, allows for the identification of sepsis, i.e., infection with organ damage). The correlation of the NEWS2 + procalcitonin association with in-hospital mortality, the percentage of admissions to intensive/sub-intensive care, and the length of hospital stay will then be assessed. These analyses will be conducted by subdividing the population based on the presence or absence of active neoplasm. Summary tables will report and describe the characteristics of the patients enrolled in the study for both the total cohort and the sub-cohorts (oncological and non-oncological patients).
Descriptive statistical analyses will be used to summarize the collected data: continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles; discrete or nominal variables will be reported using absolute frequencies and relative percentages. The distribution of continuous variables will be assessed through graphical visualization and the Kolmogorov-Smirnov correction test. Depending on the characteristics of the distribution, Chi-Square tests, Student's T-test, Mann-Whitney U test, and Wilcoxon tests will be used.
To address the primary objectives of the study, the following methodologies will be employed: the correlation between serum procalcitonin levels and NEWS2 will be examined using box plots. To assess whether procalcitonin may have independent incremental prognostic value from NEWS2 variables, a logistic regression model will be utilized. Procalcitonin values will be entered into the model as predefined ordinal scales to facilitate clinical application. We will then compare the predictive value of NEWS2 and NEWS2 + procalcitonin ordinal class. The predictive value of each model will first be calculated using the C-statistic or AUROC. Kaplan-Meier curves will also be used to evaluate the performance of procalcitonin and NEWS2.
To address the secondary objectives of the study, ROC analysis and Kaplan-Meier curves will be utilized. Data will be processed using IBM SPSS statistical software (version 28.0), and a p-value < 0.05 will be considered statistically significant.
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 presenting to the general Emergency Department for fever and/or other signs or symptoms of infection
Key inclusion criteria (2 listed)
- Patients presenting to the general Emergency Department of the IRCCS AOU of Bologna - S. Orsola Polyclinic for fever and/or other signs or symptoms of infection (for a period of 12 months following the date of study approval by the ethics committee and subsequent authorization by the General Director)
- Age ≥ 18 years - Obtaining informed consent (if possible, as specified in the protocol)
Key exclusion criteria (2 listed)
- Patients with confirmed or suspected viral infections
- Pregnancy
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
Death during hospitalization
Time frame: through study completion, an average of 2 year
The percentage of patients who died during hospitalization, those admitted to intensive/sub-intensive care, and the length of hospital stay through the assessment of the prognostic significance of NEWS2 and the NEWS2 + PCT association in the entire population hospitalized for infection from the Emergency Department
Died during hospitalization (oncological patients)
Time frame: through study completion, an average of 2 year
The percentage of patients who died during hospitalization, those admitted to intensive/sub-intensive care, and the length of hospital stay in the subpopulation of oncological patients through the evaluation of the role of PCT, the SOFA score, NEWS2, and the NEWS2 + PCT association in predicting the prognosis of oncological patients admitted for infection from the Emergency Department
2 secondary outcomes
Role of PCT as a predictive indicator of sepsis by SOFA score
Time frame: through study completion, an average of 2 year
Presence of any differences in the prognostic significance of PCT (procalcitonin)
Time frame: through study completion, an average of 2 year
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 7 Jan 2025.
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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.
Antonella Viola, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 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: finished, as of the sponsor's last update on 7 Jan 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?
Death during hospitalization (time frame: through study completion, an average of 2 year). The study lists 2 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 7 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.