Clinical Trials Directory

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UnknownNCT04388293

Using Antibiotics Wisely - An Antimicrobial Stewardship Program

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

Status
Unknown
Phase
Study type
Observational
Enrollment
2,000 (estimated)
Sponsor
University of British Columbia · Academic / Other
Sex
All
Age
22 Weeks – 44 Weeks
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERExposure of interestVery Low Birth Weight infants admitted to tertiary NICUs in Canada.

Timeline

Start date
2020-01-01
Primary completion
2025-09-30
Completion
2025-09-30
First posted
2020-05-14
Last updated
2021-12-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04388293. Inclusion in this directory is not an endorsement.