Infection, BacterialANTOINENCT03163628
biomArkers to differeNtiate bacTerial From vIral iNfEctions
A study testing Diagnostic performances of a combination of biomarkers in people with Infection, Bacterial and Infection Viral, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 36 months
- Conditions the study is for
- Infection, Bacterial, Infection Viral
- What is being tested?
- Diagnostic performances of a combination of biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 983 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Jun 2017to 12 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hospices Civils de Lyon
Bron, 69500
Hôpital Louis Mourier - APHP
Colombes, 92700
Hôpital Nord Ouest
Gleizé, 69655
About this study
Official title: Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.
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
- Being tested
- Diagnostic performances of a combination of biomarkers
- Keywords
- severe bacterial infection, acute infection, infection viral, biomarker combination, diagnostic, child
- Medical subject headings
- Bacterial Infections, Virus Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic performances of a combination of biomarkersBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 7 biomarkers combination | Experimental | Not described Receives: Biological: Diagnostic performances of a combination of biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at Day 7
Secondary outcomes (2)
Diagnosis of viral infection
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.
Measured: at Day 7
Unfavorable evolution
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
Measured: at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start6 Jun 2017
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves GILLET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163628
- Sponsor's protocol ID
- 69HCL16_0799
- Acronym
- ANTOINE
- Status last verified
- Dec 2025
- First submitted
- 22 May 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32359149
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.
- ClinicalTrials.gov ID
- NCT03163628
- Acronym / sponsor ID
- ANTOINE / 69HCL16_0799
- Conditions
- Infection, Bacterial, Infection Viral
- Keywords
- severe bacterial infection, acute infection, infection viral, biomarker combination, diagnostic, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 983 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7 biomarkers combination | Experimental | Biological: Diagnostic performances of a combination of biomarkers |
Who may qualify
- Ages
- 7 days to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Febrile children:
- Patient with national health cover
- Consent form signed by at least one parent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic performances of a combination of biomarkers3 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. | Biological | 7 biomarkers combination |
Primary outcome
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).
2 secondary outcomes
Diagnosis of viral infection
Time frame: at Day 7
Unfavorable evolution
Time frame: at Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 32359149Trouillet-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.
- Individual participant dataSharing planned: No
Related trials for Infection, Bacterial
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves GILLET, MD principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic performances of a combination of biomarkers in people with Infection, Bacterial and Infection Viral, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of severe bacterial infection (SBI) (time frame: at Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.