{
  "abstract": "Objective To evaluate whether a point-of-care decision rule could safely reduce antibiotic prescriptions in children presenting with fever without source in emergency departments.Design Open cluster randomised clinical trial (registered on ClinicalTrials.gov).Setting Twenty-five European paediatric emergency departments participated from November 2018 to October 2021.Patients Children aged 6 days to 36 months presenting with acute fever without source.Interventions During the first year, all centres (or clusters) followed their usual care protocols. In the second year, centres were randomised 1:1 to either continue usual care or to adopt the decision rule based on age, clinical symptoms, urine analysis and point-of-care procalcitonin measurements. In the third year, all centres applied the decision rule.Main outcomes and measures The primary outcome was antibiotic exposure within 15 days. Secondary outcomes included morbidity and mortality assessed at day 15.Results Among 4882 children (median age: 3 months, IQR 1–14), 2440 were in the usual care group and 2442 in the decision rule group. Serious bacterial infections occurred in 766 (15.7%) children, and invasive bacterial infections in 67 (1.4%). In the intention-to-treat analysis, 927 children (38.0%) received antibiotics within 15 days in the usual care group, compared with 641 (26.2%) in the decision rule group (OR 0.57; 95% CI 0.43 to 0.75; p<0.001). Morbidity and mortality rates were similar between groups (OR 0.83; 95% CI 0.57 to 1.22; p=0.34).Conclusions The decision rule safely reduced unnecessary antibiotic use in young children with fever without source in emergency departments.Trial registration number NCT03607162.",
  "authors": [
    {
      "affiliations": [
        "Pediatric Emergency Department, University Hospital Centre Nantes, F-44000 Nantes, France",
        "Clinical Investigation Centre INSERM 1413, Centre Hospitalier Universitaire de Nantes Pole Hospitalo-universitaire 5 Femme Enfant Adolescent, F-44000 Nantes, Pays de la Loire, France"
      ],
      "name": "David Malorey"
    },
    {
      "affiliations": [
        "Université de Tours, Tours, Centre-Val de Loire, France",
        "INSERM UMR 1246 SPHERE, F-44000 Nantes, Pays de la Loire, France"
      ],
      "name": "Elsa Tavernier"
    },
    {
      "affiliations": [
        "Clinical Investigation Centre INSERM 1413, Centre Hospitalier Universitaire de Nantes Pole Hospitalo-universitaire 5 Femme Enfant Adolescent, F-44000 Nantes, Pays de la Loire, France"
      ],
      "name": "Anne Drouard"
    },
    {
      "affiliations": [
        "Pediatric Emergency Department, University Hospital Centre Nantes, F-44000 Nantes, France"
      ],
      "name": "Bénédicte Vrignaud"
    },
    {
      "affiliations": [
        "Pediatric Department, CHU de Bordeaux, Bordeaux, France"
      ],
      "name": "Marion Bailhache"
    },
    {
      "affiliations": [
        "University Hospital of Montpellier Division of Woman Mother and Child, Montpellier, Occitanie, France"
      ],
      "name": "Gael Guyon"
    },
    {
      "affiliations": [
        "Department of Pediatric Emergency Care, Robert-Debré Mother-Child University Hospital Division of Paediatric Medicine, Paris, Île-de-France, France"
      ],
      "name": "Luigi Titomanlio"
    },
    {
      "affiliations": [
        "Pediatric emergency unit, University Hospital Centre Toulouse, Toulouse, Midi-Pyrénées, France"
      ],
      "name": "Camille Bréhin"
    },
    {
      "affiliations": [
        "CHU de Brest, Brest, Brittany, France"
      ],
      "name": "Lydie Abalea"
    },
    {
      "affiliations": [
        "Pediatrics, Geneva University Hospitals, Geneva, Switzerland"
      ],
      "name": "Alain Gervaix"
    },
    {
      "affiliations": [
        "Service de pédiatrie-urgences, Hopital Louis-Mourier, F-92700 Colombes, France",
        "Universite Paris Cite, Paris, Île-de-France, France"
      ],
      "name": "Romain Basmaci"
    },
    {
      "affiliations": [
        "Paediatric Emergency Unit & Infectious Diseases, CHU de Lille Pôle Femme Mère et Nouveau-né, F-59000 Lille, Hauts-de-France, France",
        "ULR2694, METRICS: Evaluation des technologies de santé et des pratiques médicales, METRICS ULR 2694, F-59000 Lille, Hauts-de-France, France"
      ],
      "name": "François Dubos"
    },
    {
      "affiliations": [
        "Lenval Foundation, Nice, Provence-Alpes-Côte d’Azur, France"
      ],
      "name": "Antoine Tran"
    },
    {
      "affiliations": [
        "CHU de Rennes, Rennes, Brittany, France"
      ],
      "name": "Marie Desgranges"
    },
    {
      "affiliations": [
        "Clinical Investigation Centre INSERM 1413, Centre Hospitalier Universitaire de Nantes Pole Hospitalo-universitaire 5 Femme Enfant Adolescent, F-44000 Nantes, Pays de la Loire, France",
        "General Pediatrics Department, University Hospital Centre Nantes, Nantes, France"
      ],
      "name": "Elise Launay"
    },
    {
      "affiliations": [
        "Clinical Investigation Centre INSERM 1413, Centre Hospitalier Universitaire de Nantes Pole Hospitalo-universitaire 5 Femme Enfant Adolescent, F-44000 Nantes, Pays de la Loire, France",
        "Pediatric Emergency Department, University Hospital Centre Nantes, Nantes, France"
      ],
      "name": "Christele Gras-Leguen"
    },
    {
      "affiliations": [],
      "name": "On behalf of The Diafever Study Group"
    }
  ],
  "title": "Point-of-care decision rule for antibiotic prescriptions in young children with fever without source: an open cluster randomised trial",
  "uid": "7be5f5b4-85a9-55dd-be4c-9d5e33c38980"
}