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NextGen - Clinical Implication of Next Generation Sequencing

NCT ID: NCT05206500

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Antibiotic

Intervention Type DRUG

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

Next Gen

Intervention Type DEVICE

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

Interventions

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Antibiotic

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

Intervention Type DRUG

Next Gen

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

Intervention Type DEVICE

Other Intervention Names

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Ampicillin/Amoxicillin Antifolates Cephalosporins Clindamycin Extended spectrum penicillins Fluoroquinolones Fosfomycin Linezolid Metronidazole Nitrofurantoin Penicillins Tetracyclines

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Majid Mirzazadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

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Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Majid Mirzazadeh, MD

Role: CONTACT

Phone: 336-716-4310

Email: [email protected]

Sachin N Vyas, MS, PhD

Role: CONTACT

Phone: 336-713-4098

Email: [email protected]

Facility Contacts

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Majid Mirzazadeh, MD

Role: primary

Sachin N Vyas, MS, PhD

Role: backup

Other Identifiers

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IRB00073565

Identifier Type: -

Identifier Source: org_study_id