NextGen - Clinical Implication of Next Generation Sequencing

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05206500

Collaborator

(none)

100

Enrollment

Location

Arm

6.5

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Drug: Antibiotic Device: Next Gen	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Symptomatic Patients with low Colony Count Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result.	Drug: Antibiotic FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000 Other Names: Ampicillin/Amoxicillin Antifolates Cephalosporins Clindamycin Extended spectrum penicillins Fluoroquinolones Fosfomycin Linezolid Metronidazole Nitrofurantoin Penicillins Tetracyclines Device: Next Gen Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.

Arm

Intervention/Treatment

Other: Symptomatic Patients with low Colony Count

Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result.

Drug: Antibiotic

FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000

Other Names:

Ampicillin/Amoxicillin

Antifolates

Cephalosporins

Clindamycin

Extended spectrum penicillins

Fluoroquinolones

Fosfomycin

Linezolid

Metronidazole

Nitrofurantoin

Penicillins

Tetracyclines

Device: Next Gen

Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.

Outcome Measures

Primary Outcome Measures

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
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) [3 Weeks Post-Treatment]
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 Outcome Measures

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"
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 [3 Weeks Post-Treatment]
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"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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