Using Antibiotics Wisely - An Antimicrobial Stewardship Program

NCT04388293 | Unknown

• 1 other identifier: H19-02490
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Antimicrobial Stewardship; Prematurity; Neonate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.

  2020-2025

Interventions

Exposure of interest OTHER

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

Eligibility Criteria

• Age: 22 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• infants with major congenital anomalies

Sponsors & Collaborators

• University of British Columbia: lead
• University of Calgary: collaborator
• University of Toronto: collaborator
• Memorial University of Newfoundland: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• Université de Montréal: collaborator

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33303471 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis; Premature Birth

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Joseph Ting, Associate Prof

CONTACT

+1(780)248-5408; joseph.ting@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: January 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)