Using Antibiotics Wisely - An Antimicrobial Stewardship Program

Antimicrobial Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04388293
• Other study ID #: H19-02490
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2021
• Source: University of British Columbia
• Contact: Joseph Ting, Associate Prof
• Phone: +1(780)248-5408
• Email: joseph.ting[@]ualberta.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Weeks to 44 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• infants with major congenital anomalies

Related Conditions & MeSH terms

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

Intervention

Other:
• Exposure of interest
Very Low Birth Weight infants admitted to tertiary NICUs in Canada.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (6)

Lead Sponsor	Collaborator
University of British Columbia	Children's Hospital of Eastern Ontario, Memorial University of Newfoundland, Université de Montréal, University of Calgary, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of therapy/1000 patient-day of each category of antimicrobial consumption		2020-2025
Primary	Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay		2020-2025
Secondary	Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.		2020-2025