Clostridium DifficileFIRSTNCT03848689
FQ Restriction for the Prevention of CDI
An observational study of Clostridium Difficile and Clostridium Difficile Infection, run by University of Wisconsin, Madison at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clostridium Difficile, Clostridium Difficile Infection, C Difficile Colitis
- What is being tested?
- fluoroquinolone preprescription authorization
- How many people
- 5,871 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2019to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Medical-surgical intensive care units with a FQ restriction in place as part of their usual care procedures will be excluded.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
St. Luke's Health System
Kansas City, Missouri, 64112
Gundersen Health Systems
La Crosse, Wisconsin, 54601
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705
Riverside University Health System Medical Center
Moreno Valley, California, 92555
Mayo-Arizona
Phoenix, Arizona, 85054
Mayo-Rochester
Rochester, Minnesota, 55905
About this study
Official title: Fluoroquinolone Restriction Ofr the Prevention of C. Difficile Infection (CDI)_the FIRST Trial
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.
Read the detailed description
The objective of the proposed study is to evaluate the effectiveness and implementation of a fluoroquinolone (FQ) Preprescription Authorization (PPA) as an antibiotic stewardship (AS) strategy to target and prevent CDI, promote appropriate antibiotic use, and reduce the transmission of resistant bacteria. This will contribute to the long-term goal of reducing the burden of Clostridium difficile infection (CDI), which is an essential step in improving the safety and quality of healthcare. FQ PPA is a particularly promising AS strategy to reduce CDI. Although FQs are one of the most frequently utilized classes of antibiotics in inpatient acute care facilities and are closely associated with risk for CDI, FQ usage has not been the focus of control efforts in endemic settings in the US. The proposed study will use an effectiveness-implementation hybrid type 2 design to simultaneously evaluate the efficacy of an FQ PPA intervention to reduce CDI as well as the key considerations for implementing such an intervention successfully. Intensive care units in acute care hospitals throughout Wisconsin will participate in this stepped wedge cluster randomized controlled trial. The specific aims for the proposed study are to: 1) determine the impact of a FQ PPA on hospital-onset and healthcare-associated CDI rates and other clinical outcomes compared with usual care; and 2) evaluate the implementation of FQ PPA using a systems engineering approach. For aim 1, electronic health record data will be used to evaluate the impact of the FQ PPA on hospital-onset and healthcare-associated CDI, as well as other important clinical outcomes. For aim 2, surveys and interviews with healthcare providers will be used to evaluate the contextual, implementation, and work system factors that contribute to successful implementation of a FQ PPA intervention. In addition to addressing an urgent need to identify effective AS strategies, this study will provide a framework to implement and evaluate other interventions for healthcare-acquired infection (HAI) prevention. Regardless of the results, the proposed study will generate data, tools and methods with widespread applicability for AS initiatives in healthcare-associated infection prevention.
- Being tested
- fluoroquinolone preprescription authorization, Control
- Medical subject headings
- Clostridium Infections, Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoroquinolone preprescription authorizationOther
Also called FQ PPA
Requires authorization from Infection Control consult prior to prescribing fluoroquinolone
ControlOther
Also called No FQ PPA
Does not require authorization from Infection Control prior to prescribing fluoroquinolone
| Study group | Role | What they receive |
|---|---|---|
| FQ PPA Group | Fluoroquinolone Preprescription Authorization from Infection Control consult, once, prior to prescribing fluoroquinolone Receives: Other: fluoroquinolone preprescription authorization | |
| Control Group | No preprescription authorization needed from Infection control prior to prescribing fluoroquinolone Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 Months
Secondary outcomes (8)
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.
Measured: 24 months
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.
Measured: 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.
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.
Measured: 24 months
Hospital Mortality Rate of Participants
Hospital mortality
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 May 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Nasia Safdar, MD PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848689
- Sponsor's protocol ID
- 2018-0852
- Other IDs
- 1R01HS026226-01, A534265, SMPH/MEDICINE/MEDICINE*I, Protocol ver 5.0 20 Dec 2020
- Acronym
- FIRST
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2018
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34187821
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroquinolone Restriction Ofr the Prevention of C. Difficile Infection (CDI)_the FIRST Trial
- ClinicalTrials.gov ID
- NCT03848689
- Acronym / sponsor ID
- FIRST / 2018-0852
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,871 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the proposed study is to evaluate the effectiveness and implementation of a fluoroquinolone (FQ) Preprescription Authorization (PPA) as an antibiotic stewardship (AS) strategy to target and prevent CDI, promote appropriate antibiotic use, and reduce the transmission of resistant bacteria. This will contribute to the long-term goal of reducing the burden of Clostridium difficile infection (CDI), which is an essential step in improving the safety and quality of healthcare. FQ PPA is a particularly promising AS strategy to reduce CDI. Although FQs are one of the most frequently utilized classes of antibiotics in inpatient acute care facilities and are closely associated with risk for CDI, FQ usage has not been the focus of control efforts in endemic settings in the US. The proposed study will use an effectiveness-implementation hybrid type 2 design to simultaneously evaluate the efficacy of an FQ PPA intervention to reduce CDI as well as the key considerations for implementing such an intervention successfully. Intensive care units in acute care hospitals throughout Wisconsin will participate in this stepped wedge cluster randomized controlled trial. The specific aims for the proposed study are to: 1) determine the impact of a FQ PPA on hospital-onset and healthcare-associated CDI rates and other clinical outcomes compared with usual care; and 2) evaluate the implementation of FQ PPA using a systems engineering approach. For aim 1, electronic health record data will be used to evaluate the impact of the FQ PPA on hospital-onset and healthcare-associated CDI, as well as other important clinical outcomes. For aim 2, surveys and interviews with healthcare providers will be used to evaluate the contextual, implementation, and work system factors that contribute to successful implementation of a FQ PPA intervention. In addition to addressing an urgent need to identify effective AS strategies, this study will provide a framework to implement and evaluate other interventions for healthcare-acquired infection (HAI) prevention. Regardless of the results, the proposed study will generate data, tools and methods with widespread applicability for AS initiatives in healthcare-associated infection prevention.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FQ PPA Group | – | Other: fluoroquinolone preprescription authorizationFluoroquinolone Preprescription Authorization from Infection Control consult, once, prior to prescribing fluoroquinolone |
| Control Group | – | Other: ControlNo preprescription authorization needed from Infection control prior to prescribing fluoroquinolone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Medical-surgical intensive care units with a FQ restriction in place as part of their usual care procedures will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluoroquinolone preprescription authorizationAlso: FQ PPARequires authorization from Infection Control consult prior to prescribing fluoroquinolone | Other | FQ PPA Group |
| ControlAlso: No FQ PPADoes not require authorization from Infection Control prior to prescribing fluoroquinolone | Other | Control Group |
Primary outcome
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
Time frame: 24 Months
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.
Change in the overall incidence of HO-CDI before and after initiating FQ PPA intervention
Time frame: 24 months
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.
Change in incidence of healthcare-associated CDI (HA-CDI) before and after initiation of FQ PPA intervention
Time frame: 24 Months
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.
8 secondary outcomes
Change in the usage of FQ from the time of participant hospital admission per 1000 patient-days.
Time frame: 24 months
Change in usage of non-FQ antibiotics per patient admission, and days of therapy per 1000 PD
Time frame: 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.
Time frame: 24 months
Hospital Mortality Rate of Participants
Time frame: 24 months
Length of Participants's Hospital Stay
Time frame: 24 months
Number of Participants Readmitted within 30 Days
Time frame: 24 months
Number of Incidences of Hospital Acquired Infections
Time frame: 24 months
Baseline proportion of CDI due to NAP-1 in site ICUs and associated facilities.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 34187821Safdar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasia Safdar, MD PhD principal investigator
University of Wisconsin, Madison
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile and Clostridium Difficile Infection, run by University of Wisconsin, Madison at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.