Clinical trial NCT04388293: Using Antibiotics Wisely - An Antimicrobial Stewardship Program
Official title: Using Antibiotics Wisely - Development of National Neonatal Intensive Care Unit-specific ASP
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multi-Drug Resistant Organisms
Late-Onset Sepsis, Neonatal
Antimicrobial Resistance
Keywords: Antimicrobial Stewardship
Prematurity
Neonate
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: University of Toronto
name: Memorial University of Newfoundland
name: Children's Hospital of Eastern Ontario
name: Université de Montréal
First posted: 2020-05-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 22
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* infants with major congenital anomalies

Primary outcomes:
measure: Days of therapy/1000 patient-day of each category of antimicrobial consumption
timeFrame: 2020-2025
measure: Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay
timeFrame: 2020-2025
Secondary outcomes:
measure: Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.
timeFrame: 2020-2025
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
References:
citation: 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.