Using Antibiotics Wisely - An Antimicrobial Stewardship Program

Recruiting

• Conditions: Antimicrobial Resistance; Multi-Drug Resistant Organisms; Late-Onset Sepsis, Neonatal

• Registration Number: NCT04388293
• Lead Sponsor: University of British Columbia

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-10
• Study First Posted: 2020-05-14
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-28
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

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Exclusion Criteria

• infants with major congenital anomalies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada