biomArkers to differeNtiate bacTerial From vIral iNfEctions
NCT ID: NCT03163628
Last Updated: 2025-12-19
Study Results
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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COMPLETED
NA
983 participants
INTERVENTIONAL
2017-06-06
2019-06-12
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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7 biomarkers combination
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
7 Days
36 Months
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Yves GILLET, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hospices Civils de Lyon
Bron, , France
Hôpital Louis Mourier - APHP
Colombes, , France
Hôpital Nord Ouest
Gleizé, , France
Countries
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References
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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.
Other Identifiers
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69HCL16_0799
Identifier Type: -
Identifier Source: org_study_id