Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in Children (PED_BIOMARKERS)

February 27, 2025 updated by: Elisabetta Venturini, Meyer Children's Hospital IRCCS

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy
        • Meyer Children's Hospital IRCCS, Firenze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diagnostic Test
Patients with fever (body temperature ≥38°C) for less than 7 days
Diagnostic test: Biological sample
Biomarker test for tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein of 10 kDa (IP-10), and C-reactive protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with concordance between biochemical test result and clinical diagnosis
Time Frame: From the date of enrollment to the date of diagnosis
From the date of enrollment to the date of diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED_BIOMARKER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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