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NextGen - Clinical Implication of Next Generation Sequencing

NCT05206500 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Majid Mirzazadeh, MD · Wake Forest Health Sciences

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05206500 on ClinicalTrials.gov