Recruiting

Antibiotic Reduction

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06976125

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decision Aid-prediction model

Study Details

Brief summary:

Urinary tract infection (UTI) is when bacteria enter the urinary system and cause an infection. UTIs cause symptoms including burning when peeing, a feeling of an increased urge to pee, and cloudy or strong-smelling urine. Sometimes, severe UTIs can also cause fever, abdominal pain, and/or lower back pain.

In the emergency department (ED), healthcare providers rely on symptoms, along with a urine analysis and a urine culture to diagnose a UTI. A urine analysis involves taking a sample of urine and analyzing different factors like color, acidity, presence of blood cells, presence of bacteria. An abnormal urine analysis increases the likelihood that patients might have a UTI, but it does not confirm it. A positive urine analysis will lead to provider's sending a sample of urine for a urine culture. A urine culture is used to grow whatever bacteria is in the collected urine. If growth is seen on the culture, then this confirms a patient has a UTI. This also specifies which bacteria grew on the culture. The lab can also take it a step further and do an antibiotic test to check which antibiotic the bacteria is sensitive to.

When a urine analysis comes back abnormal in an ER setting, patients are prescribed an antibiotic before the culture and antibiotic sensitivity tests come back. If a patients condition is not critical, they will be discharged home before the culture results come back. If the culture comes back positive, the pharmacists will evaluate the culture and antibiotic sensitivity tests, then call patients to inform them whether they are taking a suitable antibiotic.

This study aims to decrease the unnecessary use of antibiotics because this contributes to antibiotic resistance which is considered a global public health issue. Antibiotic resistance occurs when bacteria develop the ability to withstand certain antibiotics that used to be effective against them, which makes it difficult to treat the infection. One of the factors that increase the risk of antibiotic resistance is the overuse of antibiotics.

In this study, investigators will be incorporating a prediction model and a negative callback system to decrease unnecessary antibiotic use.

Conditions

Urinary Tract Infections

Study ID

NCT06976125

Start date

Feb 20, 2026

Status verified date

Jul, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

47 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Presenting to ER for Urinary Tract Infection (UTI)

Patients presenting to the a UH ER location for UTI symptoms.

Interventions

Decision Aid-prediction model

ER physician will input the necessary de-identified data into the decision aid application.

The decision aid determines if the patient has a high or low likelihood of having a positive urine culture. The patient with high likelihood of positive culture, will be prescribed empiric antibiotics per the UH guidelines for treating UTI in the ambulatory setting. Patients with a low likelihood of having a positive culture, will be discharged without antibiotics.

Study team members will give the patient a handout describing what will happen in the event of a positive or negative culture.

The culture call-back team, consisting of clinical pharmacists, will be notified.

Primary outcome measure

  • Number of antibiotic free days as measured by medical record review. [ Time Frame: Up to 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • ER visits
  • Antibiotic use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-07-06.