Clinical trial NCT03163628: biomArkers to differeNtiate bacTerial From vIral iNfEctions
Official title: Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection, Bacterial
Infection Viral
Keywords: severe bacterial infection
acute infection
infection viral
biomarker combination
diagnostic
child
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 983
Sex: ALL
Minimum age (years): 7
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* undergoing surgery within 7 days before inclusion

Primary outcomes:
measure: Diagnosis of severe bacterial infection (SBI)
timeFrame: at Day 7
Secondary outcomes:
measure: Diagnosis of viral infection
timeFrame: at Day 7
measure: Unfavorable evolution
timeFrame: at Day 7
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Colombes
country: France
facility: Hôpital Louis Mourier - APHP
city: Gleizé
country: France
facility: Hôpital Nord Ouest
Study officials:
affiliation: Hospices Civils de Lyon
name: Yves GILLET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.