NCT03163628

biomArkers to differeNtiate bacTerial From vIral iNfEctions

Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 983 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 7 Days – 36 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Diagnostic performances of a combination of biomarkers	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.

Timeline

• Start date: 2017-06-06
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2017-05-23
• Last updated: 2025-12-19

Locations

3 sites across 1 country: France