CompletedNot Applicable

biomArkers to differeNtiate bacTerial From vIral iNfEctions

France983 participantsStarted 2017-06-06

Plain-language 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.

Who can participate

Age range

7 Days – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnosis of severe bacterial infection (SBI)

Timeframe: at Day 7

Trial details

NCT IDNCT03163628

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-12

View on ClinicalTrials.gov More Infection, Bacterial trials