Compliance With AntibIotic TherapY Guidelines in French PICUs
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Observational [Patient Registry]

Summary: 
      This observational, prospective, multicenter study, conducted in nine French Pediatric and
      Neonatal Intensive Care Units (ICUs), will assess the antibiotic therapy for a child
      hospitalized in ICU and receiving systemic antibiotics for an episode of suspected or proven
      community-acquired or nosocomial bacterial infection. The study will describe the mean
      duration of antibiotic therapy, as well as compliance with the recommendations concerning the
      duration of antibiotic therapy, the choice of antibiotics, the daily dosage and the number of
      doses per 24 hours according to the type of bacterial infection. Patients will be monitored
      until the end of their hospitalization.
    

Detailed description: 
      Bacterial infections are widespread in Pediatric and Neonatal ICU, and antibiotic treatments
      are widely used. The Surviving Sepsis Campaign (SSC) recommends the early administration of
      empiric broad-spectrum antibiotic therapy in the event of suspected bacterial infection, with
      de-escalation once the pathogen is identified and sensitivities established. Standard-of-care
      of antibiotic treatment and duration is determined by the type of infection, microbiological
      results, and clinical biological evolution (improvement is demonstrated by reduction of
      fever, pain, and local signs as well as a decrease of the biological inflammatory syndrome
      [leukocyte count, C-reactive protein]) and/or radiological evolution, according to published
      guidelines: French guidelines (Société de Pathologie Infectieuse de Langue Française [SPILF],
      Groupe de Pathologies Infectieuses en Pédiatrie [GPIP], Société Française d'Anesthésie et de
      Réanimation [SFAR], Société de Réanimation de Langue Française [SRLF], Haute Autorité de
      Santé [HAS]), European guidelines (European Society of Clinical Microbiology and Infectious
      Diseases [ESCMID]), American guidelines (Infectious Diseases Society of America [IDSA],
      American Society of Clinical Oncology [ASCO]), and Australian guidelines (Australasian
      Society for Infectious Diseases). These recommendations are numerous. Compliance with these
      recommendations has never been evaluated in Pediatric and Neonatal ICU. Long courses of
      antibiotic treatment increase the duration of hospitalization and are associated with changes
      in the microbiome, emergence of multidrug resistant organisms, and antibiotic-associated
      adverse events (toxicity, overdose, allergy). On the other hand, too short antibiotic therapy
      can expose the patient to a risk of infection recurrence.

      The 2020 SSC pediatric guidelines identified the use of procalcitonin to guide antimicrobial
      therapy and its relationship to patients' outcome as a future research opportunity. However,
      in order to demonstrate a decrease in the antibiotic course in the PCT-guided antibiotic
      therapy group compared with the standard-of-care antibiotic therapy group in future
      interventional studies in critically ill children, calculating the number of subjects
      required demands knowledge of the mean duration of antibiotic therapy and the standard
      deviation (SD) in the standard group. These data are unknown in France.

      In this context, the study suggest evaluating the mean duration of antibiotic therapy for a
      child hospitalized in a French Pediatric and Neonatal ICU and receiving systemic antibiotics
      for an episode of suspected or proven community-acquired or nosocomial bacterial infection,
      as well as compliance with recommendations concerning the antibiotic duration, the choice of
      antibiotics, the daily dose and the number of doses per 24 hours according to the type of
      bacterial infection.

      This is a French observational, prospective, multicenter study in Pediatric and Neonatal ICU.
      All children hospitalized in Pediatric or Neonatal ICU and receiving systemic (intravascular,
      intramuscular or oral) antibiotic treatment for a suspected or proven community-acquired or
      nosocomial bacterial infection are eligible. The day of antibiotic therapy initiation at
      appropriate doses for the suspected or proven bacterial infection corresponds to day 0 (D0).
      Detailed information about the bacterial infection type (including origin of the infection
      [community or nosocomial], initially infection site(s), final diagnosis for the episode [no
      bacterial infection, presumed bacterial infection, or documented bacterial infection], sepsis
      severity according to 2005 International Pediatric Sepsis Consensus conference [IPSC],
      infection site(s) ultimately identified, causative bacteria, multidrug-resistant bacteria,
      bacteremia, presence or absence of toxinic signs/infected thrombophlebitis/infective
      endocarditis/secondary localization), acute organ dysfunctions (2005 IPSC, Pediatric Logistic
      Organ Dysfunction-2 [PELOD-2], and Pediatric Sequential Organ Failure Assessment [pSOFA]
      scores), antimicrobial, non-infectious associated treatment, and any antibiotics-related
      adverse effects will be will be prospectively openly recorded by medical study site
      investigators and reported in a standardized Case Report Form (CRF) every day until cessation
      of antibiotics in hospital (in ICU and in general department if antibiotic therapy is not
      completed in the ICU). At the end of hospitalization, a visit will be conducted to collect
      dates of discharge from the ICU and hospital, patient clinical status on discharge, detailed
      data from the ambulatory antibiotic therapy for the first episode based on discharge medical
      prescription (if the patient is discharged from hospital with antibiotic treatment for the
      first bacterial infection), recurrence of infection occurring in the same hospital stay as
      for the first episode, detailed antibiotic therapy for infection recurrence according to the
      patient's medical file for recurrence's antibiotics in hospital and to the medical
      prescription for recurrence's antibiotics continued in ambulatory care, and any
      antibiotics-related adverse effects.

      For the entire study population, the same pediatric infectious disease expert committee will
      analyze the gap between treatment and current recommendations (choice of antibiotics, daily
      dose, number of doses administered per 24 hours and total duration of antibiotic therapy).
      For each type of infection, the mean duration (SD) of antibiotic treatment administered will
      be compared with the recommended duration of antibiotic therapy.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Any child hospitalized in Pediatric or Neonatal ICU and receiving systemic (intravascular,
        intramuscular or oral) antibiotic treatment for less than 24 hours with appropriate dosages
        for an episode of suspected or proven community-acquired or nosocomial bacterial infection.
      
Keywords: Children; Pediatric Intensive Care Unit; Antibiotic duration; Compliance; Guidelines