Prediction tool to guide antibiotic decisions for urinary tract infections after ER visits
Official title: Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting
Run by University Hospitals Cleveland Medical Center · NCT06976125 · Data updated 2026-11-12
This project tests whether a prediction model used at ED discharge can help doctors decide if adult women with a suspected UTI need antibiotics.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 47 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | February 20, 2026 |
| Main results expected | December 1, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT06976125 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (over 18) discharged from the emergency department with a UTI diagnosis who were prescribed an antibiotic and are not pregnant or catheter-dependent.
✕Probably not a fit
Men, pregnant people, patients with chronic urinary catheters, very high-acuity ED patients, and those being admitted are excluded and would not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial implements a decision aid—a prediction model—at the point of emergency department discharge to guide antibiotic prescribing for suspected urinary tract infections. Eligible participants are adult women discharged from the ED with a UTI-related discharge code who were prescribed antibiotics; men, pregnant patients, catheterized patients, and high-acuity or admitted patients are excluded. The model uses clinical and laboratory features available at discharge (such as urinalysis and clinical presentation) to estimate the likelihood of true infection and inform prescribing decisions. Outcomes will focus on how the decision aid changes antibiotic use and aligns treatment with culture-confirmed infections.
Why it matters
Potential benefit: If successful, this could reduce unnecessary antibiotic use and improve targeting of antibiotics to patients with confirmed infections.
How similar studies have gone: Similar decision-support and antibiotic stewardship approaches in outpatient and ED settings have shown promise, but prediction-model guidance for UTI discharge decisions is relatively novel with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex * Age \>18 years old * Discharged from the hospital after ER visit * Discharge ICD code consistent with a UTI diagnosis * Antibiotic prescribed for UTI at the time of discharge Exclusion Criteria: * Male sex * Necessity for chronic bladder catheterization or discharge with a urinary catheter * Patients who have an Emergency Severity Index (ESI) of 1 and 2 * Patients who verbalize to the study team member that their pain is a 6 or higher * Patient set to be transferred to inpatient care * History of bladder augmentation * Pregnancy (this will be confirmed with a negative pregnancy test which is ordered in the ER)
Where it's running
-
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Jessica Abou Zeki
- Email: Jessica.AbouZeki@UHhospitals.org
- Phone: 216-286-0603
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.