NextGen - Clinical Implication of Next Generation Sequencing
Primary Purpose
Urinary Tract Infections
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Antibiotic
Next Gen
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Tract Infections
Eligibility Criteria
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
Sites / Locations
- Wake Forest Health SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Symptomatic Patients with low Colony Count
Arm Description
Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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"
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"
Full Information
NCT ID
NCT05206500
First Posted
January 7, 2022
Last Updated
February 27, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05206500
Brief Title
NextGen - Clinical Implication of Next Generation Sequencing
Official Title
Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Symptomatic Patients with low Colony Count
Arm Type
Other
Arm Description
Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result.
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Other Intervention Name(s)
Ampicillin/Amoxicillin, Antifolates, Cephalosporins, Clindamycin, Extended spectrum penicillins, Fluoroquinolones, Fosfomycin, Linezolid, Metronidazole, Nitrofurantoin, Penicillins, Tetracyclines
Intervention Description
FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000
Intervention Type
Device
Intervention Name(s)
Next Gen
Intervention Description
Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.
Primary Outcome Measure Information:
Title
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
Description
NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000. Result Measure: NGS CC 100 to 10,000
Time Frame
Baseline
Title
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
Description
NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000, Result Measure: NGS CC 100 to 10,000
Time Frame
3 Weeks Post-Treatment
Secondary Outcome Measure Information:
Title
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
Description
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"
Time Frame
Baseline
Title
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
Description
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"
Time Frame
3 Weeks Post-Treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Majid Mirzazadeh, MD
Phone
336-716-4310
Email
mmirzaza@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin N Vyas, MS, PhD
Phone
336-713-4098
Email
svyas@wakehealth.ed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Mirzazadeh, MD
Organizational Affiliation
Wake Forest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Majid Mirzazadeh, MD
Phone
336-716-4310
Email
mmirzaza@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Sachin N Vyas, MS, PhD
Phone
336-713-4098
Email
svyas@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Majid Mirzazadeh, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data are not planned to be shared. All subject related information will be available under the subject ID.
Learn more about this trial
NextGen - Clinical Implication of Next Generation Sequencing
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