Using Antibiotics Wisely - An Antimicrobial Stewardship P... | NCT04388293

Studies
Using Antibiotics Wisely - An Antimicrobial Stewardship Program

NCT04388293

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Dec 28, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

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

Interventions

Exposure of interest

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

May 10, 2020

First Submission Date that Met QC Criteria

May 10, 2020

First Posted Date

May 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2021

Last Update Posted Date

Dec 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph Ting, Principal Investigator, University of AlbertaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Name	Class
University of Calgary	OTHER
University of Toronto	OTHER
Memorial University of Newfoundland	OTHER
Children's Hospital of Eastern Ontario

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exposure of interest	Other	Very Low Birth Weight infants admitted to tertiary NICUs in Canada.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.		2020-2025

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

infants with major congenital anomalies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Weeks

Maximum Age

44 Weeks

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joseph Ting, Associate Prof	Contact	+1(780)248-5408		joseph.ting@ualberta.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Alexandra Hospital	Recruiting	Edmonton	Alberta	T5H 3V9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33303471	Derived	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.

ID	Term
D000071074	Neonatal Sepsis
D047928	Premature Birth

ID	Term
D018805	Sepsis
D007239	Infections
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities