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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05206500
Other study ID # IRB00073565
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 17, 2022
Est. completion date June 2026

Study information

Verified date January 2024
Source Wake Forest University Health Sciences
Contact Majid Mirzazadeh, MD
Phone 336-716-4310
Email mmirzaza@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Female 18 to 80 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Wake Forest Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000. Result Measure: NGS CC 100 to 10,000 Baseline
Primary Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000, Result Measure: NGS CC 100 to 10,000 3 Weeks Post-Treatment
Secondary Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 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" Baseline
Secondary Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 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" 3 Weeks Post-Treatment
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