Infection, Bacterial Clinical Trial
— ANTOINEOfficial title:
Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.
NCT number | NCT03163628 |
Other study ID # | 69HCL16_0799 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 6, 2017 |
Est. completion date | June 12, 2019 |
Verified date | June 2019 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 983 |
Est. completion date | June 12, 2019 |
Est. primary completion date | June 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 36 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hospices Civils de Lyon | Bron | |
France | Hôpital Louis Mourier - APHP | Colombes | |
France | Hôpital Nord Ouest | Gleizé |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
at Day 7 | |
Secondary | 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. |
at Day 7 | |
Secondary | 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 |
at Day 7 |
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