NCT06976125 Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting
| NCT ID | NCT06976125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Urinary Tract Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2026-02-20 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 47 participants in total. It began in 2026-02-20 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
David Sheyn, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT06976125 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06976125 currently recruiting?
Yes, NCT06976125 is actively recruiting participants. Contact the research team at Jessica.AbouZeki@UHhospitals.org for enrollment information.
Where is the NCT06976125 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06976125 clinical trial?
NCT06976125 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is David Sheyn, MD at University Hospitals Cleveland Medical Center. The trial plans to enroll 47 participants.