Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

biomArkers to differeNtiate bacTerial From vIral iNfEctions (ANTOINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03163628
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Infection, Bacterial Infection Viral Biological: Diagnostic performances of a combination of biomarkers Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 985 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 13, 2019
Estimated Study Completion Date : June 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 7 biomarkers combination 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.




Primary Outcome Measures :
  1. Diagnosis of severe bacterial infection (SBI) [ Time Frame: at Day 7 ]

    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).



Secondary Outcome Measures :
  1. Diagnosis of viral infection [ Time Frame: at Day 7 ]

    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 this secondary outcome, the SBI class will group (4) proved viral infection, (5) presumed viral infection.


  2. Unfavorable evolution [ Time Frame: at Day 7 ]

    Evaluate the possible association between biomarkers concentration and patient unfavorable evolution, defined as:

    • For hospitalized patient : entry in a health department with an higher level of care or death within 7 days after study inclusion
    • For non-hospitalized patient : hospitalization or death within 7 days after study inclusion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163628


Contacts
Layout table for location contacts
Contact: Yves GILLET, MD 427 865 642 ext +33 yves.gillet@chu-lyon.fr
Contact: Tiphanie Ginhoux 427 857 723 ext +33 tiphanie.ginhoux@chu-lyon.fr

Locations
Layout table for location information
France
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Yves GILLET, MD    427 865 642 ext +33    yves.gillet@chu-lyon.fr   
Contact: Tiphanie Ginhoux    427 857 723 ext +33    tiphanie.ginhoux@chu-lyon.fr   
Principal Investigator: Yves GILLET, MD         
Sub-Investigator: Aurélie Portefaix, MD         
Hôpital Louis Mourier - APHP Not yet recruiting
Colombes, France, 92700
Contact: BASMACI Romain, MD    01 47 60 63 58 ext +33    romain.basmaci@aphp.fr   
Sub-Investigator: Nina Droz, MD         
Principal Investigator: Romain BASMACI, MD         
Hôpital Nord Ouest Not yet recruiting
Gleizé, France, 69655
Contact: Philippe REBAUD, MD    04 74 09 28 53 ext +33    prebaud@lhopitalnordouest.fr   
Principal Investigator: Philippe REBAUD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Yves GILLET, MD Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03163628     History of Changes
Other Study ID Numbers: 69HCL16_0799
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
severe bacterial infection
acute infection
infection viral
biomarker combination
diagnostic
child

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Bacterial Infections
Virus Diseases