DNA PCR vs Urine Culture for Urinary Tract Infection

Overseen by David Sheyn, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Hospitals Cleveland Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.

Research Team

David Sheyn, MD

Principal Investigator

University Hospitals

Eligibility Criteria

This trial is for adults over 18 with symptoms of a urinary tract infection (UTI). They must be willing to fill out questionnaires and can participate for up to 21 days. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have Medicare or Medicaid insurance.

I am an adult with UTI or cystitis symptoms.

Exclusion Criteria

I have had surgery to redirect urine flow.

Pregnant patients

Chronic indwelling urinary catheter

Treatment Details

Interventions

• DNA Polymerase Chain Reaction (Procedure)

Trial Overview The study compares two methods of diagnosing UTIs: traditional urine culture and DNA PCR testing. Participants will be randomly placed in one of the two groups and followed up after antibiotic treatment.

Participant Groups

Group I: DNA Polymerase Chain Reaction (PCR) Experimental Treatment 1 Intervention

Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.

Group II: Urine Culture Active Control 1 Intervention

Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+