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

NCT ID: NCT06852846

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Febrile Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic Test

Patients with fever (body temperature ≥38°C) for less than 7 days

Group Type OTHER

Biological sample

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meyer Children's Hospital IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Elisabetta Venturini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meyer Children's Hospital IRCCS, Firenze

Florence, Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 36043485 (View on PubMed)

Other Identifiers

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PED_BIOMARKER

Identifier Type: -

Identifier Source: org_study_id