NCT06976125 · University Hospitals Cleveland Medical Center
Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations