136 Participants Needed

DNA PCR vs Urine Culture for Urinary Tract Infection

DN
Overseen ByDiana N Mitchell, MD, MBA, BSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.

Is DNA PCR generally safe for diagnosing urinary tract infections?

The research does not provide specific safety data for DNA PCR in diagnosing urinary tract infections, but PCR is a widely used method in various medical tests and is generally considered safe for humans.12345

How does DNA PCR treatment differ from other treatments for urinary tract infections?

DNA PCR (polymerase chain reaction) is a unique treatment for urinary tract infections because it uses molecular methods to identify bacteria directly from urine samples, unlike traditional urine cultures that may miss some infections. This approach can detect bacteria that are not identified by standard culture methods, potentially leading to more accurate and timely diagnosis.14678

What data supports the effectiveness of the treatment DNA Polymerase Chain Reaction for urinary tract infections?

Research shows that PCR testing is more effective than traditional urine culture in detecting a wider range of bacteria, including those that are difficult to grow in cultures, leading to better diagnosis and treatment of urinary tract infections.1491011

Who Is on the Research Team?

DS

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

I have had surgery to redirect urine flow.
Pregnant patients
Chronic indwelling urinary catheter
See 5 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: DNA Polymerase Chain Reaction (PCR)Experimental Treatment1 Intervention
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
Group II: Urine CultureActive Control1 Intervention
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Citations

The Essential Role of PCR and PCR Panel Size in Comparison with Urine Culture in Identification of Polymicrobial and Fastidious Organisms in Patients with Complicated Urinary Tract Infections. [2023]
Real-time polymerase chain-reaction detection of pathogens is feasible to supplement the diagnostic sequence for urinary tract infections. [2019]
Improving Patient Outcomes While Reducing Empirical Treatment with Multiplex-Polymerase-Chain-Reaction/Pooled-Antibiotic-Susceptibility-Testing Assay for Complicated and Recurrent Urinary Tract Infections. [2023]
Molecular Diagnostic Methods Versus Conventional Urine Culture for Diagnosis and Treatment of Urinary Tract Infection: A Systematic Review and Meta-analysis. [2022]
Hidden pathogens uncovered: metagenomic analysis of urinary tract infections. [2011]
[Microbiological diagnosis of urinary tract infections]. [2017]
Urinary bacteria in adult women with urgency urinary incontinence. [2021]
Utility of urine cultures in the emergency department. [2019]
Usefulness of next-generation DNA sequencing for the diagnosis of urinary tract infection. [2020]
Accuracy of molecular diagnostic techniques in patients with a confirmed urine culture: A systematic review and meta-analysis. [2022]
Urinary cell-free DNA is a versatile analyte for monitoring infections of the urinary tract. [2019]
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