Febrile IllnessPED_BIOMARKERSNCT06852846
Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in Children
A study testing Biological sample in people with Febrile Illness, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
Fever can be a clinical manifestation present in pediatric infections, posing a challenge for the doctor who must decide whether or not to prescribe an antibiotic therapy. Routine blood tests can assist the doctor in making a decision, although their response times often do not allow for timely therapeutic decisions. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Febrile Illness
- What is being tested?
- Biological sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 3 months and < 18 years
- Access to the Emergency Department during the study period
- Fever (body temperature ≥38°C) for less than 7 days
- Absence of an infectious focus or symptoms affecting the respiratory tract
Who cannot join
- Fever for more than 7 days
- Antibiotic therapy for ≥ 48 hours
- Acute gastroenteritis
- HBV (hepatitis B virus) or HCV (hepatitis C virus) infection
- Active oncologic pathology
- Metabolic pathology
- Trauma or major surgery within the past 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in a Cohort of Pediatric Febrile Patients
Fever can be a clinical manifestation present in pediatric infections, posing a challenge for the doctor who must decide whether or not to prescribe an antibiotic therapy. Routine blood tests can assist the doctor in making a decision, although their response times often do not allow for timely therapeutic decisions. Therefore, there is an increased risk of inappropriate prescribing antibiotics for children with viral infections, which contributes to the increase in antibiotic resistance. There is evidence suggesting the effectiveness of certain biomarkers in distinguishing viral from bacterial forms. Biomarkers of potential interest include tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein of 10 kDa (IP-10), and C-reactive protein. The combination of those tests could distinguish between bacterial and viral infections with 90-94% sensitivity, 88-92.8% specificity, 59-81% positive predictive value and 97-98.8% negative predictive value. This is prospective study using biological samples that aims to evaluate the best diagnostic algorithm for obtaining an early and accurate etiological diagnosis (bacterial infection vs viral infection) of a febrile pediatric patient presenting at the Emergency Department, by comparing the standard algorithm with the diagnostic algorithm integrated with the results of the multi-analytic test.
- Conditions
- Febrile Illness
- Being tested
- Biological sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampleDiagnostic test
Biomarker test for tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein of 10 kDa (IP-10), and C-reactive protein
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test | Other | Patients with fever (body temperature ≥38°C) for less than 7 days Receives: Diagnostic Test: Biological sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with concordance between biochemical test result and clinical diagnosis
Measured: From the date of enrollment to the date of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start23 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Febrile IllnessStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabetta Venturini, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852846
- Sponsor's protocol ID
- PED_BIOMARKER
- Acronym
- PED_BIOMARKERS
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papan C, Argentiero A, Adams O, Porwoll M, Hakim U, Farinelli E, Testa I, Pasticci MB, Mezzetti D, Perruccio K, Simon A, Liese JG, Knuf M, Stein M, Yacobov R, Bamberger E, Schneider S, Esposito S, Tenenbaum T. Association of viral load with TRAIL, IP-10, CRP biomarker signature and disease severity in children with respiratory tract infection or fever without source: A prospective, multicentre cohort study. J Med Virol. 2023 Jan;95(1):e28113. doi: 10.1002/jmv.28113. Epub 2022 Sep 9.
PubMed 36043485
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in a Cohort of Pediatric Febrile Patients
- ClinicalTrials.gov ID
- NCT06852846
- Acronym / sponsor ID
- PED_BIOMARKERS / PED_BIOMARKER
- Conditions
- Febrile Illness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Feb 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.
Fever can be a clinical manifestation present in pediatric infections, posing a challenge for the doctor who must decide whether or not to prescribe an antibiotic therapy. Routine blood tests can assist the doctor in making a decision, although their response times often do not allow for timely therapeutic decisions. Therefore, there is an increased risk of inappropriate prescribing antibiotics for children with viral infections, which contributes to the increase in antibiotic resistance. There is evidence suggesting the effectiveness of certain biomarkers in distinguishing viral from bacterial forms. Biomarkers of potential interest include tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein of 10 kDa (IP-10), and C-reactive protein. The combination of those tests could distinguish between bacterial and viral infections with 90-94% sensitivity, 88-92.8% specificity, 59-81% positive predictive value and 97-98.8% negative predictive value. This is prospective study using biological samples that aims to evaluate the best diagnostic algorithm for obtaining an early and accurate etiological diagnosis (bacterial infection vs viral infection) of a febrile pediatric patient presenting at the Emergency Department, by comparing the standard algorithm with the diagnostic algorithm integrated with the results of the multi-analytic test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test | Other | Diagnostic Test: Biological samplePatients with fever (body temperature ≥38°C) for less than 7 days |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age ≥ 3 months and < 18 years
- Access to the Emergency Department during the study period
- Fever (body temperature ≥38°C) for less than 7 days
- Absence of an infectious focus or symptoms affecting the respiratory tract
Key exclusion criteria (7 listed)
- Fever for more than 7 days
- Antibiotic therapy for ≥ 48 hours
- Acute gastroenteritis
- HBV (hepatitis B virus) or HCV (hepatitis C virus) infection
- Active oncologic pathology
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 |
|---|---|---|
| Biological sampleBiomarker test for tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein of 10 kDa (IP-10), and C-reactive protein | Diagnostic test | Diagnostic Test |
Primary outcome
Percentage of patients with concordance between biochemical test result and clinical diagnosis
Time frame: From the date of enrollment to the date of diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 36043485Papan C, Argentiero A, Adams O, Porwoll M, Hakim U, Farinelli E, Testa I, Pasticci MB, Mezzetti D, Perruccio K, Simon A, Liese JG, Knuf M, Stein M, Yacobov R, Bamberger E, Schneider S, Esposito S, Tenenbaum T. Association of viral load with TRAIL, IP-10, CRP biomarker signature and disease severity in children with respiratory tract infection or fever without source: A prospective, multicentre cohort study. J Med Virol. 2023 Jan;95(1):e28113. doi: 10.1002/jmv.28113. Epub 2022 Sep 9.
- 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?
A study testing Biological sample in people with Febrile Illness, run by Meyer Children's Hospital 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 28 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of patients with concordance between biochemical test result and clinical diagnosis (time frame: From the date of enrollment to the date of diagnosis). 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 NCT06852846, 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 28 Feb 2025.