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Recruiting NCT05206500

NextGen - Clinical Implication of Next Generation Sequencing

Phase IV Interventional Urinary Tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antibiotic, Next Gen.
Who it may be relevant to
Registry conditions: Urinary Tract Infections. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture

Overview

Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.

Detailed description

Bacterial sensitivity test for different antibiotics are the most important guide for treatment of patients with UTI. Unfortunately, for patients with less than 10,000 Colony Count (CC), usually no sensitivity test is done and there is not any guide for appropriate antibiotic therapy for this group.

Interventions

  • Drug Antibiotic
    FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000
  • Device Next Gen
    Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.

Primary outcome measures

  • Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) [Time frame: Baseline]
  • Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) [Time frame: 3 Weeks Post-Treatment]
Secondary outcome measures (2)
  • Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 [Time frame: Baseline]
  • Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 [Time frame: 3 Weeks Post-Treatment]

Eligibility criteria

Inclusion criteria

  • Female at least 18 years of age
  • U/C (Urinary Culture) growth of <10,000 Colony-Forming Units (CFU)
  • Understanding and acceptance of the need to return for all scheduled follow-up visits
  • Able to give informed consent

Exclusion criteria

  • Catheter in use (Foley or suprapubic or intermittent)
  • Not able to provide clean midstream urine
  • Antibiotic consumption in the past 2 weeks before signing the consent
  • Pregnant or Planning to Conceive
  • Incarcerated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Wake Forest Health Sciences — Winston-Salem

Identifiers

NCT: NCT05206500 · IRB00073565

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗