biomArkers to differeNtiate bacTerial From vIral iNfEctions

NCT03163628 | Completed

• 1 other identifier: 69HCL16_0799
• Study Type: interventional
• Target: 983
• Locations: 1 country
• Sites: 3

Brief Summary

ANTOINE is a prospective trial which aims to assess diagnostic performance of 7 biomarkers for the diagnosis of severe bacterial infections (SBI) in children aged from 7 days to 36 months. Fever is a frequent cause of consultation in pediatric emergency departments. Clinical diagnostic tools are rare and discrimination between severe bacterial infection and viral infection is difficult to confidently state. The prevalence of severe bacterial infections (IBS) varies from 10 to 25% according to the studies. Biological markers such as procalcitonin (PCT) and C-reactive protein (CRP) are commonly used in clinical practice. These markers have bacterial specificity but share a wide range of values with viral infections and do not make it possible to exclude or to confirm definitively the diagnosis of IBS. The use of new markers to improve the diagnosis of bacterial and viral infections is increasingly studied in adults. The diagnostic value of these new markers has been demonstrated by associating their dosage with that of CRP for example. This is the case for IP-10, TRAIL or MxA. However, very few pediatric studies have been carried out to date on these new biomarkers. However, in pediatrics, these diagnostic tools based on the combination of biomarkers to discriminate against viral and bacterial infections could be a major help in the suspicions of IBS. 7 biomarkers were selected to be evaluated in this study. This study is designed to determine the best biomarkers combination for the SBI diagnosis on a cohort of 800 patients.

Conditions

Infection, Bacterial; Infection Viral

Keywords

severe bacterial infection; acute infection; infection viral; biomarker combination; diagnostic; child

Outcome Measures

Primary Outcomes (1)

• Diagnosis of severe bacterial infection (SBI)

  Diagnostic performance of the biomarkers combination will be compared to the diagnostic performances of CRP alone and PCT alone, based on the adjudication committee classification (gold standard). The Adjudication Committee will sort patients in 6 different groups according to their clinical data: (1) proved SBI, (2) presumed SBI, (3) both viral \& bacterial infection, (4) proved viral infection, (5) presumed viral infection, \& (6) not classifiable patient. To answer the primary outcome, the SBI class will group proved SBI (1), presumed SBI (2) and both viral \& bacterial infection (3).

  at Day 7

Secondary Outcomes (2)

• Diagnosis of viral infection

  at Day 7

• Unfavorable evolution

  at Day 7

Study Arms (1)

7 biomarkers combination

EXPERIMENTAL

Biological: Diagnostic performances of a combination of biomarkers

Interventions

Diagnostic performances of a combination of biomarkers BIOLOGICAL

3 ml of blood will be drawn at inclusion at the same time of the venipuncture prescribed for standard care. The dosage of the 7 biomarkers will be performed in a central laboratory. The adjudication committee will classify patients in 6 groups, based on their clinical data. The committee will not be aware of the biological results. The analysis of Train Set data will aim to identify the most effective combination of markers in response to the primary objective of identifying biomarkers for the diagnosis of severe bacterial infections. The best combination selected will then be applied to the Test Set data (approximately the other half of patients), in order to obtain its real and unbiased performance. The calculation of positive and negative likelihood ratios will be performed. The targeted performances are: * A positive likelihood ratio (LR +) of 5.67 minimum, ideally greater than 8.5. * A negative likelihood ratio (LR-) of 0.5 maximum, ideally less than 0.3.

7 biomarkers combination

Eligibility Criteria

• Age: 7 Days - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Febrile children:
• Between 7 days and 3 months old : fever \>38°C for more than 6 hours (late neonatal fever suspected) for which the physician prescribed venipuncture
• Between 3 months and 36 months old : fever ≥38,5°C for more than 6 hours and less than 7 days for which the physician prescribed venipuncture for suspected severe bacterial infection
• Patient with national health cover
• Consent form signed by at least one parent

You may not qualify if:

• Children treated by antibiotherapy within the past 48h
• Children with congenital or acquired immunodeficiency syndrome or long-term immunosuppression treatment
• Vaccinated children within 48h by an inactivated vaccine or within 10 days for the MMR vaccines
• Children with a chronic disease

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hospices Civils de Lyon

Bron, 69500, France

Location

Hôpital Louis Mourier - APHP

Colombes, 92700, France

Location

Hôpital Nord Ouest

Gleizé, 69655, France

Location

Related Publications (1)

• Trouillet-Assant S, Viel S, Ouziel A, Boisselier L, Rebaud P, Basmaci R, Droz N, Belot A, Pons S, Brengel-Pesce K, Gillet Y, Javouhey E; Antoine Study Group. Type I Interferon in Children with Viral or Bacterial Infections. Clin Chem. 2020 Jun 1;66(6):802-808. doi: 10.1093/clinchem/hvaa089.

  PMID: 32359149 RESULT

MeSH Terms

Conditions

Bacterial Infections; Virus Diseases; Disease

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yves GILLET, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: June 6, 2017
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)