Actively Recruiting
Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting
Led by University Hospitals Cleveland Medical Center · Updated on 2026-04-08
47
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Urinary tract infections (UTIs) occur when bacteria enter the urinary system causing symptoms like burning during urination, increased urge to urinate, and cloudy or strong-smelling urine. Severe cases may include fever, abdominal pain, or lower back pain. This research evaluates a prediction model and negative callback system to reduce unnecessary antibiotic use, addressing antibiotic resistance, a global health issue caused by overuse of antibiotics. In this study, emergency room physicians will use a decision aid application to input patient data. This tool predicts the likelihood of a positive urine culture. Patients deemed likely to have an infection will be prescribed antibiotics following hospital guidelines, while those unlikely to have an infection will be discharged without antibiotics. Pharmacists will monitor culture results and contact patients if antibiotic adjustments are needed. Participants are patients presenting to the ER with UTI symptoms and discharged with antibiotics. Participants will be followed for up to two weeks after the ER visit. Researchers will review medical records to measure antibiotic-free days, antibiotic prescription rates, hospitalizations, ER readmissions, and unscheduled primary care visits. They will also assess the accuracy of urine analysis against culture results and track any non-UTI urologic diagnoses. The study aims to improve antibiotic use and monitor patient outcomes after ER discharge.
CONDITIONS
Brief Title
Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Age greater than 18 years
- Discharged from the hospital after an ER visit
- Discharge diagnosis code consistent with a urinary tract infection
- Antibiotic prescribed for urinary tract infection at discharge
You will not qualify if you...
- Male sex
- Need for chronic bladder catheterization or discharge with a urinary catheter
- Emergency Severity Index of 1 or 2
- Pain level of 6 or higher reported to study staff
- Planned transfer to inpatient care
- History of bladder augmentation
- Pregnancy confirmed by a negative pregnancy test in the ER
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants presenting to the emergency room for urinary tract infection symptoms will have their data entered into a decision aid prediction model. Based on the model's results, participants with a high likelihood of positive urine culture will be prescribed empiric antibiotics, while those with a low likelihood will be discharged without antibiotics. Participants will receive information about potential outcomes depending on culture results.
1 visit at the emergency room and follow-up through medical record review
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
J
Jessica Abou Zeki
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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