FQ Restriction for the Prevention of CDI
FIRST
Fluoroquinolone Restriction Ofr the Prevention of C. Difficile Infection (CDI)_the FIRST Trial
5 other identifiers
observational
5,871
1 country
7
Brief Summary
This study evaluates the effectiveness of a new intervention, fluoroquinolone (FQ) Preprescription Authorization (PPA) strategy, to reduce and prevent Clostridium difficile infection (CDI) in hospital intensive care units (ICUs). The investigators will model a successful FQ PPA strategy in several Wisconsin ICUs and compare whether the intervention has improved outcomes in reducing CDIs. An additional goal of the study is to evaluate environmental and work system factors using systems engineering models in order to determine the most successful way to implement these new strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2018
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedJanuary 31, 2025
January 1, 2025
5.1 years
October 2, 2018
January 29, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Change in the incidence of healthcare facility-onset Clostridiodes difficile infection (HO-CDI) with intensive care unit (ICU)-onset before and after initiating FQ PPA intervention
Effectiveness of fluoroquinolone (FQ) Pre-prescription Authorization (PPA) intervention to reduce HO-CDI with ICU-onset will be assessed by comparing changes in incidence over pre- and post-intervention periods.
24 Months
Change in the overall incidence of HO-CDI before and after initiating FQ PPA intervention
Effectiveness of FQ PPA intervention to reduce HO-CDI will be assessed by calculating changes in incidence over pre- and post-FQ PPA intervention periods.
24 months
Change in incidence of healthcare-associated CDI (HA-CDI) before and after initiation of FQ PPA intervention
Effectiveness of FQ PPA intervention to reduce HA-CDI will be assessed by calculating changes in incidence over pre- and post-FQ PPA intervention periods.
24 Months
Secondary Outcomes (8)
Change in the usage of FQ from the time of participant hospital admission per 1000 patient-days.
24 months
Change in usage of non-FQ antibiotics per patient admission, and days of therapy per 1000 PD
24 months
Change in the number of patients per site showing Acute Kidney Injury (AKI) using the Kidney Disease Improving Global Outcomes (KDIGO) guideline definition.
24 months
Hospital Mortality Rate of Participants
24 months
Length of Participants's Hospital Stay
24 months
- +3 more secondary outcomes
Study Arms (2)
FQ PPA Group
Fluoroquinolone Preprescription Authorization from Infection Control consult, once, prior to prescribing fluoroquinolone
Control Group
No preprescription authorization needed from Infection control prior to prescribing fluoroquinolone
Interventions
Requires authorization from Infection Control consult prior to prescribing fluoroquinolone
Does not require authorization from Infection Control prior to prescribing fluoroquinolone
Eligibility Criteria
The study population is comprised of clinicians and patients at 12 ICUs in 5 acute care hospitals. Once initiated, the intervention will be applied to all patients admitted to the ICU and all healthcare workers involved in antibiotic prescribing in that ICU.
You may qualify if:
- Medical-surgical intensive care unit with at least 10 beds
- Presence of existing antibiotic stewardship (AS) program with pharmacist and ID physician support
- Electronic health record (EHR) vendor is Epic Systems Corporation
- Has ability to extract antibiotic usage data (days of therapy)
- Has ability to extract required outcomes data (CDI, mortality, length of ICU stay)
- Ability to extract or abstract data on indications for antibiotic use
- Adherence to best practices for infection control relevant to CDI
You may not qualify if:
- Medical-surgical intensive care units with a FQ restriction in place as part of their usual care procedures will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Mayo-Arizona
Phoenix, Arizona, 85054, United States
Riverside University Health System Medical Center
Moreno Valley, California, 92555, United States
Mayo-Rochester
Rochester, Minnesota, 55905, United States
St. Luke's Health System
Kansas City, Missouri, 64112, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555, United States
Gundersen Health Systems
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705, United States
Related Publications (1)
Safdar N, Parmasad V, Brown R, Carayon P, Lepak A, O'Horo JC, Schulz L. Decreasing ICU-associated Clostridioides difficile infection through fluoroquinolone restriction, the FIRST trial: a study protocol. BMJ Open. 2021 Jun 29;11(6):e046480. doi: 10.1136/bmjopen-2020-046480.
PMID: 34187821DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nasia Safdar, MD PhD
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2018
First Posted
February 21, 2019
Study Start
May 1, 2019
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
January 31, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share