Compliance With AntibIotic TherapY Guidelines in French PICUs

NCT04642560 | Completed

• 1 other identifier: RC31/20/0416
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Infections

Keywords

Children; Pediatric Intensive Care Unit; Antibiotic duration; Compliance; Guidelines

Outcome Measures

Primary Outcomes (1)

• Percentage of patients (%) for whom there is a gap between practices and current recommendations regarding the duration of antibiotic therapy (between beginning of antibiotics and cessation of antibiotics)

  It includes only the length of treatment for the initial suspected or proven bacterial infection episode but not for recurrences. The duration of antibiotic therapy for the first episode of suspected or proven bacterial infection is the time interval, expressed in days, between the starting time of systemic (intravenous, intramuscular or oral) antibiotics with appropriate dosages (D0) and the stopping time of the antibiotic therapy. Detailed information about antibiotic treatment will be collected every day of hospitalization. If the patient is discharged from hospital with ambulatory antibiotic therapy for the first episode, we will refer to the discharge medical prescription for the complete antimicrobial therapy for the first bacterial infection.

  up to cessation of antibiotics in hospital up to 3 month

Secondary Outcomes (9)

• Percentage of patients (%) with recurrence of infection within 28 days following Days 0

  up to 28 days

• Mean (SD) total duration of antibiotic therapy (in days), including the first episode and recurrences within 28 days following D0.

  up to 28 days

• Mean (SD) duration of broad-spectrum antibiotic therapy (in days), including the first episode and recurrences within 28 days following D0

  up to 28 days

• Percentage of patients (%) for whom there is a gap between practices and current recommendations (between beginning of antibiotics and cessation of antibiotics)

  up to cessation of antibiotics in hospital

• Mean (SD) length of ICU stay (in days) from D0 (between beginning of antibiotics and cessation of antibiotics)

  up to the end of hospitalization

Study Arms (1)

Usual practice

Any child hospitalized in Pediatric or Neonatal ICU and receiving systemic (intravascular, intramuscular or oral) antibiotic treatment for an episode of suspected or proven community-acquired or nosocomial bacterial infection

Eligibility Criteria

• Age: 72 Hours - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Neonates, infants and children 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.
• Informed verbal consent obtained from both parents or legal guardians.

You may not qualify if:

• Newborns \<72 hours old.
• Neonates \<37 weeks of corrected gestational age.
• Age ≥18 years.
• Antibiotic prophylaxis.
• Children previously included in an interventional study in progress.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de TOULOUSE

Toulouse, 31059, France

Location

Related Publications (1)

• Amadieu R, Brehin C, Chahine A, Grouteau E, Dubois D, Munzer C, Flumian C, Brissaud O, Ros B, Jean G, Brotelande C, Travert B, Savy N, Boeuf B, Ghostine G, Popov I, Duport P, Wolff R, Maurice L, Dauger S, Breinig S. Compliance with antibiotic therapy guidelines in french paediatric intensive care units: a multicentre observational study. BMC Infect Dis. 2024 Jun 12;24(1):582. doi: 10.1186/s12879-024-09472-0.

  PMID: 38867164 DERIVED

MeSH Terms

Conditions

Bacterial Infections; Patient Compliance

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Romain AMADIEU, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: November 24, 2020
• Study Start: June 15, 2020
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

FR (1)