Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06976125

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

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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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