Urinary Tract Infections
Conditions
Brief summary
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
DRUGAntibiotic
FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000
DEVICENext Gen
Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients with Urinary Tract Infection (UTI) symptoms and Colony-forming Units (CFU) \<10,000 have clinically significant UTIs. Characterizing the species of bacteria growing in low numbers and treating the patients based on bacterial sensitivity will help in resolving patients' symptoms.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) | Baseline | NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria \<10,000. Result Measure: NGS CC 100 to 10,000 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 | Baseline | NGS result focused antibiotic treatment and symptom outcome with the measurement of King's Questionnaire Outcome. Result Measure: Mild, Moderate, and Severe UTI symptoms in last 12 and 24 hours on 7 questions with no symptoms as 0, Mild as 1, Moderate as 2, and Severe as 3 |
Countries
United States
Contacts
Primary ContactMajid Mirzazadeh, MD
Backup ContactSachin N Vyas, MS, PhD
Outcome results
None listed