Diagnosing bacterial infections in children with fever without source remains challenging. The MeMed BV score, combining C-reactive protein, interferon gamma-induced protein-10, and tumor necrosis factor-related apoptosis-inducing ligand, has shown high performance in detecting bacterial infections, mostly in adults. The objective of this study is to explore the diagnostic performance of the MeMed BV score in identifying bacterial infections in young children with fever without source. In this prospective exploratory observational study, children younger than 3 years presenting to the pediatric emergency departments with acute fever without source were eligible for inclusion. An adjudication committee reviewed clinical and microbiological data to establish the diagnosis of bacterial infection. The MeMed BV score ranged from 0 to 100, with manufacturer-validated thresholds: < 35 viral, > 65 bacterial, 35–65 equivocal. In the main analysis, equivocal scores were considered bacterial. A sensitivity analysis was subsequently performed excluding patients with equivocal scores. The performance of MeMed BV score was compared to procalcitonin. Among the 384 eligible children, 69 were analyzed. Median age was 2 months (IQR 1–10), and 25

AIM:To develop and internally validate a new severity score to more accurately assess the clinical severity forms of acute gastroenteritis (AGE) in children from birth to age 5 years. METHODS:We included children consulting for AGE in the emergency department of the University Hospital of Nantes (March 2017-June 2019). We developed and evaluated a new predictive score (GASTROVIM score) using the classification and regression trees. We compared its diagnostic performance with the two existing scores: the Vesikari score and clinical dehydration scale (CDS). A clinical expert a posteriori evaluated children's medical records to determine the severity form of AGE as the gold standard. RESULTS:Of the 200 children included, 129 (64.5%) had severe forms of AGE according to the GASTROVIM score (maximal number of liquid stools and vomiting per day, weight loss and CDS), with sensitivity 90.0% (95% CI: 83.5-94.6) and specificity 82.9% (72.0-90.8). The Vesikari score had similar sensitivity (97.3%) but lower specificity (17.0%) and the CDS had lower sensitivity (28.3%) and higher specificity (100%) than the GASTROVIM score. CONCLUSION:The GASTROVIM score could discriminate severe forms of AGE with good diagnostic performance. Nevertheless, external validation in other populations and/or other countries is needed.

OBJECTIVES:Interpreting elbow radiographs in pediatric trauma cases is challenging for emergency clinicians due to anatomical peculiarities of this joint in children and the risk of complications from missed fractures. Artificial intelligence (AI), particularly deep learning algorithms, has the potential to assist in fracture detection. We aimed to assess the performance of pediatric emergency clinicians in detecting elbow fractures in children without and with the assistance of a deep learning algorithm. PATIENTS AND METHODS:This retrospective study included all children aged 0-15 years admitted to the emergency department of a French university hospital between January 2019 and April 2020, for whom frontal and lateral elbow radiographs were ordered following trauma. The reference standard was established by two independent experts blind to the AI algorithm results. The diagnostic performance of emergency clinicians was evaluated and compared without and with the theoretical AI assistance. Additionally, the performance of the stand-alone AI algorithm was externally tested. RESULTS:Out of 755 children included (median age: 8 years), 352 (47 %) had an elbow fracture, joint effusion, and/or dislocation. The theoretical AI assistance improved clinician's sensitivity by 21.6 % (from 77.3 % to 98.9 %; p < 0.001), though this was accompanied by a 24.8 % decrease in specificity (from 88.3 % to 63.5 %; p < 0.001). The stand-alone AI algorithm achieved a sensitivity of 98.0 % (95 % CI: 96.0-99.0) and a specificity of 70.0 % (95 % CI: 65.3-74.2). CONCLUSION:The AI algorithm demonstrated high performance in detecting pediatric elbow fractures, significantly improving sensitivity for emergency clinicians and helping to reduce the rate of missed diagnoses.

Introduction:Mild traumatic brain injury (mTBI) is an important public health issue, but France does not have a dedicated epidemiological surveillance system for mTBI. Data on Emergency departments (ED) of the OSCOUR network could be useful for setting up a dedicated mTBI surveillance system. However, the performance of potential algorithms based on ICD-10 codes for identifying cases of mTBI in OSCOUR has not been assessed. The objective of this study is to measure the performance of various potential algorithms, based on ICD-10 codes, for identifying mTBI ED visits in the OSCOUR database. Material and Methods:We performed a retrospective multicenter validation study of algorithms for identifying mTBI based on ICD-10 codes using the OSCOUR database. We calculated sensitivity, specificity, positive and negative predictive values of the various algorithms by using medical charts from ED visits as a reference source. Our study population consisted of a random sample of patients of all ages in France who visited one of the four ED from the OSCOUR network, which participated in our study in 2019. Results:5,185 medical charts were reviewed. Algorithms performance varied according to population characteristics, and none of the algorithms tested for the identification of mTBI cases achieved the minimum performance requirements (sensitivity and PPV ≥ 80%) over all age or sex groups. However, sub-group analyses highlighted that one algorithm (BA31_OPT1) had acceptable performance for identifying mTBI according to our "broad" definition for people under 18 years old. Sensitivity, specificity, PPV and NPV for this algorithm were 85.2%, 99.4%, 95.2% and 98%, respectively. Conclusion:Most mTBI case identification algorithms performed poorly in identifying mTBI cases of all ages in the OSCOUR database. Nevertheless, it was possible to identify cases defined according to a "broad" mTBI definition in the paediatric population (0-17 years).

Introduction The BIOMINRISK project is a national French study aimed at identifying novel biomarkers associated with sudden unexpected death in infancy (SUDI) through a multidisciplinary approach encompassing three key components of intrinsic vulnerability to SUDI: genetic, neurobiological and radio-anatomical. A better understanding of the pathophysiological mechanisms underlying SUDI may enhance the personalisation of prevention strategies and contribute to reducing its incidence.Methods and analysis We will analyse data from 250 children under the age of 2 included in the national SUDI registry (the OMIN registry) since 2020 for which biological samples and medical imaging data will have been collected from 15 participating French hospitals. Our investigations will focus on three axes: (1) genetic: we will conduct whole genome sequencing family trio analyses to identify novel variants and genes associated with sudden infant death syndrome (SIDS) by examining SIDS cases along with their two parents; (2) neurobiological: a case-control study will be performed to investigate the roles of various neuromodulators—including serum serotonin, blood butyrylcholinesterase and cerebrospinal fluid orexin—in the arousal regulation in children who have died from SUDI. We will recruit 250 living age-matched and sex-matched controls who will undergo blood tests and lumbar punctures as part of their routine care and (3) radio-anatomical: a case-control study will explore the potential anatomical predisposition to SUDI by assessing upper airway narrowness. We will compare the osseous structures of the upper airways (nasal fossae, hard palate) using geometric morphometrics on CT images. Recruitment of 250 living age-matched and sex-matched controls who have undergone brain CT scans, including facial bones, will be conducted.Ethics and dissemination The study has received ethics approval for all three axes. Results will be published in international peer-reviewed journals and presented at national and international conferences.Trial registration number NCT06244433.

BACKGROUND:Abusive Head Trauma (AHT) is a leading cause of morbidity and mortality in infants requiring rapid neuroimaging performance and prognostic rapid diagnosis. The Pittsburgh Infant Brain Injury Score (PIBIS) clinical prediction rule (CPR) was derived to identify infants most likely to present brain injury, whose diagnosis would benefit from head CT. Our study aimed to externally validate the PIBIS CPR in a pediatric French population. METHODS:A retrospective study was conducted in a French pediatric emergency department between 2015 and 2017. We included all consecutive infants who underwent a neurological imaging. Medical data were collected, and PIBIS score was determined, both retrospectively. RESULTS:We included 129 infants among which 33 cases (including 20 with a diagnosis of AHT). The sensitivity and specificity of the PIBIS CPR were 75.8 % (95 % CI 57.7-88.9) and 61.4 % (51.0-71.2) and negative and positive predictive values 88.1 % (77.8-94.7) and 40.3 % (33.0-48.2). Among the 20 infants with a diagnosis of AHT, 19 (95.0 %) were correctly identified by the PIBIS CPR. CONCLUSION:Our external validation study found a lower diagnostic value of the PIBIS CPR than in the original study. This argues for adding biomarkers to improve its performance, notably in the context of suspected AHT.

Introduction In light of the burden of traumatic brain injury (TBI) in children and the excessive number of unnecessary CT scans still being performed, new strategies are needed to limit their use while minimising the risk of delayed diagnosis of intracranial lesions (ICLs). Identifying children at higher risk of poor outcomes would enable them to be better monitored. The use of the blood-based brain biomarkers glial fibrillar acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase-L1 (UCH-L1) could help clinicians in this decision. The overall aim of this study is to provide new knowledge regarding GFAP and UCH-L1 in order to improve TBI management in the paediatric population.Methods and analysis We will conduct a European, prospective, multicentre study, the BRAINI-2 paediatric study, in 20 centres in France, Spain and Switzerland with an inclusion period of 30 months for a total of 2880 children and adolescents included. To assess the performance of GFAP and UCH-L1 used separately and in combination to predict ICLs on CT scans (primary objective), 630 children less than 18 years of age with mild TBI, defined by a Glasgow Coma Scale score of 13–15 and with a CT scan will be recruited. To evaluate the potential of GFAP and UCH-L1 in predicting the prognosis after TBI (secondary objective), a further 1720 children with mild TBI but no CT scan as well as 130 children with moderate or severe TBI will be recruited. Finally, to establish age-specific reference values for GFAP and UCH-L1 (secondary objective), we will include 400 children and adolescents with no history of TBI.Ethics and dissemination This study has received ethics approval in all participating countries. Results from our study will be disseminated in international peer-reviewed journals. All procedures were developed in order to assure data protection and confidentiality.Trial registration number NCT05413499.

ImportanceMinor head trauma (HT) is one of the most common causes of hospitalization in children. A diagnostic test could prevent unnecessary hospitalizations and cranial computed tomographic (CCT) scans.ObjectiveTo evaluate the effectiveness of serum S100B values in reducing exposure to CCT scans and in-hospital observation in children with minor HT.Design, Setting, and ParticipantsThis multicenter, unblinded, prospective, interventional randomized clinical trial used a stepped-wedge cluster design to compare S100B biomonitoring and control groups at 11 centers in France. Participants included children and adolescents 16 years or younger (hereinafter referred to as children) admitted to the emergency department with minor HT. The enrollment period was November 1, 2016, to October 31, 2021, with a follow-up period of 1 month for each patient. Data were analyzed from March 7 to May 29, 2023, based on the modified intention-to-treat and per protocol populations.InterventionsChildren in the control group had CCT scans or were hospitalized according to current recommendations. In the S100B biomonitoring group, blood sampling took place within 3 hours after minor HT, and management depended on serum S100B protein levels. If the S100B level was within the reference range according to age, the children were discharged from the emergency department. Otherwise, children were treated as in the control group.Main Outcomes and MeasuresProportion of CCT scans performed (absence or presence of CCT scan for each patient) in the 48 hours following minor HT.ResultsA total of 2078 children were included: 926 in the control group and 1152 in the S100B biomonitoring group (1235 [59.4%] boys; median age, 3.2 [IQR, 1.0-8.5] years). Cranial CT scans were performed in 299 children (32.3%) in the control group and 112 (9.7%) in the S100B biomonitoring group. This difference of 23% (95% CI, 19%-26%) was not statistically significant (P = .44) due to an intraclass correlation coefficient of 0.32. A statistically significant 50% reduction in hospitalizations (95% CI, 47%-53%) was observed in the S100B biomonitoring group (479 [41.6%] vs 849 [91.7%]; P < .001).Conclusions and RelevanceIn this randomized clinical trial of effectiveness of the serum S100B level in the management of pediatric minor HT, S100B biomonitoring yielded a reduction in the number of CCT scans and in-hospital observation when measured in accordance with the conditions defined by a clinical decision algorithm.Trial RegistrationClinicalTrials.gov Identifier: NCT02819778

Background: Since the beginning of the pandemic, children's role in the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been debated. We aimed to describe the prevalence of SARSCoV-2 in asymptomatic children undergoing institutional systematic screening. Methods: From 2020 to 2021, this retrospective study in a French university hospital included consecutive asymptomatic children routinely screened for SARS-CoV-2 infection by polymerase chain reaction (PCR) assay before surgery. Results: Among the 816 test samples, the prevalence of positive PCR results was 0.49 % (95 % CI: 0.01-0.97, n = 4); half of the cases involved close contacts with an adult case. Conclusion: These results support the low prevalence of SARS-CoV-2 in asymptomatic children during the first pandemic periods in France. (c) 2023 Published by Elsevier Masson SAS on behalf of French Society of Pediatrics.

OBJECTIVES: To describe the distribution, consequences and potential determinants of time to antibiotics administration in children with community-onset severe bacterial infections (COSBIs). DESIGN: Secondary analysis of the available data from a prospective population-based study from 2009 to 2014. SETTING: An administrative area in western France accounting for 13% of the national pediatric population. PATIENTS: All children from 1 month to 16 years old admitted to a PICU or who died before admission and had a COSBI. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The time to antibiotics was divided into patient interval (from first signs of COSBI to the first medical consultation) and medical interval (from the first consultation to appropriate antibiotics administration). The association between the medical interval and child outcome was studied by a multinomial logistic regression model and the potential determinants of the patient and medical intervals were by a Cox proportional-hazards model. Of the 227 children included (median age 2.1 yr), 22 died (9.7%), and 21 (9.3%) had severe sequelae at PICU discharge. Median patient and medical intervals were 7.0 hours (interquartile range [IQR], 2.0–16.5 hr) and 3.3 hours (IQR, 1.1–12.2 hr), respectively. The last quartile of medical interval was not associated with death (adjusted odds ratio [aOR], 3.7; 95% CI, 0.8–17.5) or survival with severe sequelae (aOR, 1.3; 95% CI, 0.4–4.0) versus survival without severe sequelae. Patient interval was shorter in younger children (adjusted hazard ratio [aHR], 0.95; 95% CI, 0.92–0.99), and medical interval was reduced when the first consultation was conducted in a hospital (aHR, 1.5; 95% CI, 1.1–2.0) versus outpatient medicine. CONCLUSIONS: For children with COSBI, we found no significant association between medical interval and mortality or severe sequelae. An initial hospital referral could help reduce the time to antibiotics in COSBIs.

Incomplete vaccination in the pediatric population is a growing public health issue in high-income countries, but its determinants are poorly understood. Their identification is necessary to design target actions that can improve vaccination uptake. Our aim was to assess the determinants of incomplete vaccination in two-year-old children in France. Among the 18,329 children included in the 2011 ELFE French nationwide population-based birth cohort, we selected those for whom vaccination status was available at age two years. Incomplete vaccination was defined as ≥ 1 missing dose of recommended vaccines. Potential determinants of incomplete vaccination were identified by using logistic regression, taking into account attrition and missing data. Of the 5,740 (31.3

Importance:Assessment of the quality of initial care is necessary to target priority actions that can reduce the still high morbidity and mortality due to community-onset severe bacterial infections (COSBIs) among children. Objective:To study the prevalence, characteristics, and determinants of suboptimal care in the initial management of COSBIs. Design, Setting, and Participants:This prospective, population-based, cohort study and confidential enquiry was conducted between August 2009 and January 2014 in western France, a region accounting for 15% of the French pediatric population (1 968 474 children aged 1 month to 16 years) and including 6 pediatric intensive care units (PICUs) and 35 emergency departments. Participants included all children aged 1 month to 16 years who died before PICU admission or were admitted to a PICU with a COSBI (ie, bacterial sepsis, including meningitis, purpura fulminans, and pulmonary, osteoarticular, intra-abdominal, cardiac, and soft-tissue severe infections). Data were analyzed from March to June 2020. Exposures:Suboptimal care determined according to evaluation of 8 types of care: (1) the delay in seeking care by family, (2) the physician's evaluation of severity, (3) the patient's referral at the first consultation with signs of severity, (4) the timing and (5) dosage of antibiotic treatment, (6) the timing and (7) volume of fluid bolus administration, and (8) the clinical reassessment after fluid bolus. Main Outcomes and Measures:Two experts assessed the quality of care before death or PICU admission as optimal, possibly suboptimal, or certainly suboptimal. The consequences and determinants of certainly suboptimal care were identified with multinomial logistic regression and generalized linear mixed models. Results:Of the 259 children included (median [IQR] age, 24 [6-66] months; 143 boys [55.2%]), 27 (10.4%) died, and 25 (9.6%) had severe sequelae at PICU discharge. The quality of care was certainly suboptimal in 89 cases (34.4%). Suboptimal care was more frequent in children with sequelae (adjusted odds ratio [aOR], 5.61; 95% CI, 1.19-26.36) and less frequent in children who died (aOR, 0.16; 95% CI, 0.04-0.65) vs those surviving without sequelae. Factors independently associated with suboptimal care were age younger than 5 years (aOR, 3.15; 95% CI, 1.25-7.90), diagnosis of sepsis with no source (aOR, 5.77; 95% CI, 1.64-20.30) or meningitis (aOR, 3.39; 95% CI, 1.15-9.96) vs other severe infections, and care by a primary care physician (aOR, 3.22; 95% CI, 1.17-8.88) vs a pediatric hospital service. Conclusions and Relevance:This study found that suboptimal care is frequent in the initial management of COSBI and is associated with severe sequelae. The paradoxical association with reduced risk of death may be explained by an insufficient adjustment on bacterial or host intrinsic factors. Management could be optimized by improving the quality of primary care, especially for young children.

Introduction The French emergency department (ED) surveillance network OSCOUR transmits data on ED visits to Santé publique France (the national public health agency). As these data are collected daily and are almost exhaustive at a national level, it would seem relevant to use them for national epidemiological surveillance of mild traumatic brain injury (mTBI). This article presents the protocol of a planned study to validate algorithms for identifying mTBI in the OSCOUR database. Algorithms to be tested will be based on International Classification of Diseases (ICD)-10 codes. Methods and analysis We will perform a multicentre validation study of algorithms for identifying mTBI in OSCOUR. Different combinations of ICD-10 codes will be used to identify cases of mTBI in the OSCOUR database. A random sample of mTBI cases and non-cases will be selected from four EDs. Medical charts will serve as the reference standard to validate the algorithms. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the different algorithms, as well as their 95% CIs, will be calculated and compared. Ethics and dissemination The ethics committee of the French National Data Protection Authority (CNIL) approved this study (n° 921152, 1 August 2021). Results will be submitted to national and international peer-reviewed journals and presented at conferences dedicated to trauma and to methodologies for the construction and validation of algorithms.

La vaccination a permis une nette diminution des infections bactériennes sévères communautaires (IBSC) dans de nombreux pays mais elle reste encore suboptimale. Il a été démontré dans une étude conduite dans la région Grand-Ouest entre 2009 et 2014 que 25% des décès et séquelles graves précoces des IBSC à pneumocoque et méningocoque étaient évitables par une application correcte du calendrier vaccinal. Notre objectif était de confirmer ces résultats inquiétants au niveau national. Dans une étude épidémiologique descriptive observationnelle multicentrique nationale conduite dans 12 CHU en France de 2015 à 2018, tous les enfants de 0 à 18 ans avec une IBSC ayant nécessité une admission en réanimation ou décédé avant l'entrée en réanimation ont été inclus prospectivement. Une IBSC à pneumocoque ou méningocoque de sérotype/groupe ciblé par les vaccins recommandés au moment de l'infection a été jugée évitable si elle survenait chez un enfant incomplètement vacciné, selon le calendrier vaccinal en vigueur pour les enfants immunocompétents et immunodéprimés. Parmi les 177 enfants avec IBSC inclus, 86 avaient une infection à pneumocoque dont 13 à sérotypes vaccinaux, 50 non vaccinaux et 23 non disponibles et 91 une infection à méningocoque dont 61 à méningocoques B, 15 C, 8 W, 3 Y et 4 non disponibles. Huit enfants sont décédés (5%) et 40 ont eu des séquelles graves immédiates (23%). Sept sur 15 (47%, IC95% [11-61]) infections à méningocoque C et 8 sur 13 (62%, IC95% [36-88]) infections à pneumocoque à sérotype vaccinal étaient évitables. Ces infections potentiellement évitables ont été à l'origine d'un des 8 décès (12,5%) et de 6 des 40 cas de séquelles graves immédiates (15%). Parmi les infections évitables à pneumocoque, 5 étaient ciblés par le PCV 13 dont 2 enfants nés prématurés et un enfant avec une neutropénie congénitale, et 3 étaient ciblés par le PPSV 23 recommandé pour les enfants à risque (deux enfants drépanocytaires et un enfant avec une surdité profonde). Au total, parmi les enfants ciblés par au moins une des 2 vaccinations par le PCV ou le MenC, 98 (57%, IC95% [50-64]) étaient incomplètement vaccinés pour au moins une des deux vaccinations. Une meilleure sensibilisation des professionnels et du public et un élargissement de la vaccination au méningocoque B et une augmentation du nombre de sérotypes couverts pour le pneumocoque permettraient de réduire la morbi-mortalité par IBSC. Aucun lien d'intérêt

BACKGROUND:Infectious diseases are still an important cause of morbidity and mortality in high-income countries and may preferentially affect predisposed children, especially immunocompromised children. We aimed to evaluate the frequency of recommended immunological tests in children with community-onset severe bacterial infection (COSBI) admitted to a pediatric intensive care unit. We also assessed the frequency and described the typology of diagnosed primary immune deficiency (PID). METHODS:We conducted a retrospective observational epidemiological study in six university hospitals in western France. All children from 1 month to 16 years of age admitted to hospital for bacterial meningitis, purpura fulminans, or meningococcal disease between August 2009 and January 2014 were included. We analyzed the frequency, type, and results of the immunological tests performed on children with meningitis, purpura fulminans, or a meningococcemia episode. RESULTS:Among the 143 children included (144 episodes), 84 (59%) and 60 (41%) had bacterial meningitis and purpura fulminans or meningococcemia, respectively: 72 (50%) had immunological tests and 8% had a complete immunological investigation as recommended. Among the 72 children examined for PID, 11 (15%) had at least one anomaly in the immunological test results. Two children had a diagnosis of PID (one with C2 deficit and the other with C8 deficit) and seven other children had possible PID. Thus, the prevalence of a definite or possible diagnosis of PID was 12% among the children examined. CONCLUSION:PID is rarely investigated after COSBI. We raise awareness of the need for immunological investigations after a severe infection requiring PICU admission.

OBJECTIVES:To describe the epidemiology of community-onset severe bacterial infections in children and its recent evolution.DESIGN:Prospective, observational, population-based study from 2009 to 2014.SETTING:An administrative area accounting for 13% of the French pediatric population.PATIENTS:All children 1 month to 16 years old who died before admission or were admitted to a PICU for a community-onset severe bacterial infection.INTERVENTIONS:None.MEASUREMENTS AND MAIN RESULTS:The incidence and mortality rate of community-onset severe bacterial infections were compared with data from a reference population-based study conducted between 2000 and 2006, that is, before national recommendations for antimeningococcal C and antipneumococcal generalized vaccinations. Among the 261 children included (median age 25 mo), 28 (10.7%) died. The main diagnoses were meningitis (n = 85; 32%) and purpura fulminans (n = 59; 22%). The most common isolated bacteria were Neisseria meningitidis (n = 75; 29%), including 47 (63%) cases of serogroup B and 15 (20%) serogroup C, Streptococcus pneumoniae (n = 49, 19%), and Staphylococcus aureus (n = 15; 6%). The incidence of community-onset severe bacterial infections was three per 100,000 person-years (95% CI, 2.6-3.3) and had decreased by 53% from the reference period. Mortality rate was 0.3 per 100,000 person-years (95% CI, 0.2-0.4) and had decreased by 73% from the reference period. The incidence of community-onset severe bacterial infections caused by N. meningitidis and S. pneumoniae was 0.8 and 0.5 per 100,000 person-years and had decreased by 70% and 67% from the reference period. The incidence of community-onset severe bacterial infections-related to Staphylococcus aureus was 0.16 per 100,000 person-years and had increased by 220% from the reference period.CONCLUSIONS:The incidence and mortality rate of community-onset severe bacterial infections, except for S. aureus infection, have decreased in France. N. meningitidis and S. pneumoniae continue to account for many infections, which indicates the need for better vaccination coverage and spectrum.

INTRODUCTION:Fever is one of the most common reasons for consultation in the paediatric emergency department (ED). Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment. The aims of this study are to demonstrate that using a procalcitonin (PCT) rapid test-based prediction rule (1) would not be inferior to usual practice in terms of morbidity and mortality (non-inferiority objective) and (2) would result in a significant reduction in antibiotic use (superiority objective).METHODS AND ANALYSIS:This prospective multicentric cluster-randomised study aims to include 7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period. During first period, all children will receive usual care. In a second period, a point-of-care PCT-based algorithm will be used in half of the clusters. The primary endpoints collected on day 15 after ED consultation will be a composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment administered for the superiority objective. The endpoints will be compared between the two groups (experimental and control) by using a mixed logistic regression model adjusted on clustering of participants within centres and period within centres.DISCUSSION:If the algorithm is validated, a new strategy will be discussed with medical societies to safely manage fever in young children without the need for invasive procedures for microbiological testing or empirical antibiotics.ETHICS AND DISSEMINATION:This study was submitted to an independent ethics committee on 17 May 2018 (no. 2018-A00252-53). Results will be submitted to international peer-reviewed journals and presented at international conferences.TRIAL REGISTRATION NUMBER:NCT03607162; Pre-results.