Clostridium Difficile Infection Clinical Trial
— FIRSTOfficial title:
Fluoroquinolone Restriction Ofr the Prevention of C. Difficile Infection (CDI)_the FIRST Trial
Verified date | April 2024 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 11000 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Medical-surgical intensive care units with a FQ restriction in place as part of their usual care procedures will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Medical Branch at Galveston | Galveston | Texas |
United States | St. Luke's Health System | Kansas City | Missouri |
United States | Gundersen Health Systems | La Crosse | Wisconsin |
United States | University of Wisconsin Hospital & Clinics | Madison | Wisconsin |
United States | Riverside University Health System Medical Center | Moreno Valley | California |
United States | Mayo-Arizona | Phoenix | Arizona |
United States | Mayo-Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change in the usage of FQ from the time of participant hospital admission per 1000 patient-days. | To confirm fidelity of implementation of FQ PPA intervention, the change in the usage of FQ and other antibiotics in days of therapy per 1000 patient-days will be measured. | 24 months | |
Secondary | Change in usage of non-FQ antibiotics per patient admission, and days of therapy per 1000 PD | To confirm fidelity of implementation of FQ PPA intervention, the change in the usage of antibiotics other than FQ in days of therapy per 1000 patient-days will be measured. | 24 months | |
Secondary | Change in the number of patients per site showing Acute Kidney Injury (AKI) using the Kidney Disease Improving Global Outcomes (KDIGO) guideline definition. | The potential of this intervention to increase usage of alternative antibiotics with a negative clinical outcomes such as AKI, as compared with usual care, will be measured by assessing change in incidence of AKI, defined as: Increase in serum creatinine by = 0.3 mg/dl within 48 hours, or increase in serum creatinine to =1.5 times baseline or urine volume <0.5 mg/kg/hour for 6 hours. | 24 months | |
Secondary | Hospital Mortality Rate of Participants | Hospital mortality | 24 months | |
Secondary | Length of Participants's Hospital Stay | The impact of FQ PPA on negative clinical outcomes as compared with usual care by the length of hospital stay | 24 months | |
Secondary | Number of Participants Readmitted within 30 Days | The impact of FQ PPA intervention compared with usual care as it impacts the number of patients readmitted within 30 days. | 24 months | |
Secondary | Number of Incidences of Hospital Acquired Infections | The impact of FQ PPA on negative clinical outcomes as compared with usual care by the incidence of other, non-CDI hospital acquired infections. | 24 months | |
Secondary | Baseline proportion of CDI due to NAP-1 in site ICUs and associated facilities. | This would reflect whether the FQ PPA intervention was impacted by the prevalence of the strain of CDI most susceptible to FQ antibiotics. | 24 months |
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