DNA PCR vs Urine Culture for Urinary Tract Infection

Overseen By Diana N Mitchell, MD, MBA, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Antibiotics, Phenazopyridine

Disqualifiers: Urinary diversion, Catheter, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 21 days

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for diagnosing urinary tract infections (UTIs) by comparing DNA PCR (a gene analysis test) with standard urine culture. Researchers will randomly assign people with UTI symptoms to one of these groups to evaluate which method is more effective. The trial is suitable for adults with UTI symptoms who have Medicare or Medicaid insurance and have not recently had a UTI or taken antibiotics. Participants will complete questionnaires and may receive follow-up contact after finishing any prescribed antibiotics. The study lasts up to 21 days. As an unphased trial, it offers participants the chance to contribute to improving UTI diagnosis methods for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken antibiotics or phenazopyridine in the last 21 days to participate.

What prior data suggests that these methods are safe for diagnosing UTIs?

Research has shown that DNA Polymerase Chain Reaction (PCR) testing is generally safe for diagnosing urinary tract infections (UTIs). In past studies, PCR identified various germs and signs of antibiotic resistance in urine samples. This method is easy for patients to handle, with no major side effects reported. PCR testing requires no invasive procedures, making it a low-risk choice for participants. Evidence suggests that PCR testing safely aids doctors in selecting the best antibiotic treatment without harming patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to diagnose urinary tract infections (UTIs) using DNA Polymerase Chain Reaction (PCR) instead of the traditional urine culture method. Unlike urine cultures, which can take a few days to provide results, DNA PCR can detect bacterial DNA rapidly, potentially offering diagnostic results much faster. This speed can be crucial for starting appropriate treatment sooner, improving patient outcomes. Additionally, DNA PCR might be more sensitive, detecting infections that urine cultures might miss, leading to more accurate diagnoses.

What evidence suggests that DNA PCR is effective for diagnosing urinary tract infections?

This trial will compare DNA Polymerase Chain Reaction (PCR) with traditional urine culture for diagnosing urinary tract infections (UTIs). Research has shown that PCR is highly effective in diagnosing UTIs, with studies indicating a 99% sensitivity, meaning it can detect almost all UTIs when present. It also has a 94% specificity, confirming when UTIs are not present. PCR detects bacteria in urine samples more frequently than traditional urine tests; one study found bacteria in 56% of patients using PCR. This method may assist doctors in selecting the right antibiotics, potentially leading to better treatment outcomes for UTIs. Participants in this trial will be assigned to either the PCR arm or the urine culture arm to evaluate the effectiveness of these diagnostic methods. ^{1 2 4 6 7}

Who Is on the Research Team?

David Sheyn, MD

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

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

Pregnant patients

I have had surgery to redirect urine flow.

Chronic indwelling urinary catheter

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are assigned to either the urine culture group or the DNA PCR study group and may be prescribed antibiotics for UTI treatment

Up to 21 days

1 visit (in-person) for enrollment and randomization

Follow-up

Participants are monitored for symptom changes and asked to fill out questionnaires after completing antibiotics

1 day after antibiotic completion

1 call (virtual) after antibiotic completion

What Are the Treatments Tested in This Trial?

Interventions

• DNA Polymerase Chain Reaction

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11203880/

The Impact of Polymerase Chain Reaction Urine Testing ... We find that PCR test results are used by clinicians in managing cUTI, and use of this test provides an opportunity to improve antibiotic stewardship.

2. mdpi.com mdpi.com/2079-7737/13/4/257

Comparison of Polymerase Chain Reaction and Urine ... A recent meta-analysis comparing results of PCR and NGS found that PCR had a 99% sensitivity and a 94% specificity for diagnosing UTIs, while ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S009042951930963X

Multiplex PCR Based Urinary Tract Infection (UTI) Analysis ... Sixty percent of patients (60%, 347/582) had positive results by PCR, urine culture, or both. PCR detected bacteria in 56% of patients (326/582), while urine ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003360.09

LBA01-09 CLINICAL UTILITY OF POLYMERASE CHAIN ... Data suggests that polymerase chain reaction (PCR) enhances urinary pathogen detection and identification of pmUTI/FO. We sought to ascertain if ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06808451

Diagnosis and Treatment of Urinary Tract Infection Using ... Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture. ClinicalTrials.gov ID NCT06808451. Sponsor ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827067

Use of Multiplex Molecular Panels to Diagnose Urinary ... This cohort study uses Medicare fee-for-service claims data to assess the use of multiplex molecular panels to diagnose urinary tract ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9988651/

UTI detection by PCR: Improving patient outcomes - PMC We use a PCR test to identify 21 microbes and 20 antibiotic resistance markers (Table 1) that may be present in human urine specimens from patients exhibiting ...