Using Antibiotics Wisely - An Antimicrobial Stewardship Program

Using Antibiotics Wisely - Development of National Neonatal Intensive Care Unit-specific ASP

There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.

Study Overview

• Status: Recruiting
• Conditions: Antimicrobial Resistance; Multi-Drug Resistant Organisms; Late-Onset Sepsis, Neonatal
• Intervention / Treatment: Other: Exposure of interest

Detailed Description

Purpose: The investigators aim to develop and implement NICU-specific Antimicrobial Stewardship Program (ASP) strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of multi-drug resistant organisms (MDRO) in Canada.

Hypothesis: The investigators expect to find:

• Significant national variation in broad-spectrum antimicrobial use, which will not be correlated with rates of sepsis. High antimicrobial consumption rates may be associated with limited existing ASP resources and increased neonatal morbidity related to inflammatory cascades.
• Significant national variation in the prevalence of MDROs across NICUs.
• Differences in empirical antimicrobial regimens may be associated with MDRO prevalence, and the variation in antimicrobial use may explain some variation in neonatal morbidity.

Study Population and Sample Size: The study population will include very-low-birth-weight (VLBW) infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Joseph Ting, Associate Prof; Phone Number: +1(780)248-5408; Email: joseph.ting@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Recruiting
      • Royal Alexandra Hospital
      • Contact: Joseph Ting, MD, MPH; Phone Number: +1(780)248-5408; Email: joseph.ting@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all VLBW infants admitted to participating tertiary NICUs in Canada. The investigators will exclude infants with major congenital anomalies to avoid confounding factors when analyzing the impact of antimicrobial use and MDRO on neonatal outcomes. All VLBW infants will be included in the primary MDRO prevalence analysis. The investigators expect ~2000 VLBW infants with culture-proven infections in the study period.

Description

Inclusion Criteria:

• Very-low-birth-weight infants admitted to participating tertiary NICUs in Canada.

Exclusion Criteria:

• infants with major congenital anomalies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Days of therapy/1000 patient-day of each category of antimicrobial consumption	2020-2025
Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay	2020-2025

Secondary Outcome Measures

Outcome Measure	Time Frame
Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.	2020-2025

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: University of Toronto; University of Calgary; Children's Hospital of Eastern Ontario; Université de Montréal; Memorial University of Newfoundland

Publications and helpful links

General Publications

• Ting JY, Roberts A, Tilley P, Robinson JL, Dunn MS, Paquette V, Lee KS, Shah V, Yoon E, Richter LL, Lodha A, Shivananda S, Thampi N, Autmizguine J, Shah PS; Canadian Neonatal Network Investigators. Development of a national neonatal intensive care unit-specific antimicrobial stewardship programme in Canada: protocol for a cohort study. BMJ Open. 2020 Dec 10;10(12):e043403. doi: 10.1136/bmjopen-2020-043403.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 10, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Prematurity; Neonate; Antimicrobial Stewardship
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis
• Other Study ID Numbers: H19-02490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No