Using Antibiotics Wisely - An Antimicrobial Stewardship Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Multi-Drug Resistant Organisms Late-Onset Sepsis, Neonatal Antimicrobial Resistance

Keywords

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Antimicrobial Stewardship Prematurity Neonate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Exposure of interest

Very Low Birth Weight infants admitted to tertiary NICUs in Canada.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* infants with major congenital anomalies

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

44 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Joseph Ting

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Joseph Ting, Associate Prof

Role: CONTACT

Phone: +1(780)248-5408

Email: [email protected]

Facility Contacts

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Joseph Ting, MD, MPH

Role: primary

References

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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.

Reference Type DERIVED

PMID: 33303471 (View on PubMed)

Other Identifiers

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H19-02490

Identifier Type: -

Identifier Source: org_study_id