CompletedNot Applicable

FQ Restriction for the Prevention of CDI

United States5,871 participantsStarted 2019-05-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24 Months

Change in the overall incidence of HO-CDI before and after initiating FQ PPA intervention

Timeframe: 24 months

Change in incidence of healthcare-associated CDI (HA-CDI) before and after initiation of FQ PPA intervention

Timeframe: 24 Months

Trial details

NCT IDNCT03848689

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Clostridium Difficile trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 24 Months

Change in the overall incidence of HO-CDI before and after initiating FQ PPA intervention

Timeframe: 24 months

Change in incidence of healthcare-associated CDI (HA-CDI) before and after initiation of FQ PPA intervention

Timeframe: 24 Months