NextGen - Clinical Implication of Next Generation Sequencing

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05206500
Phase
PHASE4
Status
Recruiting
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Conditions

  • Urinary Tract Infections

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Antibiotic — DRUG
    FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000
  • Next Gen — DEVICE
    Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.

Study Details

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.

Key Dates

Start date
May 17, 2022
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Health SciencesWinston-SalemNorth Carolina27157
Majid Mirzazadeh, MD
[email protected]
336-716-4310
Sachin N Vyas, MS, PhD
[email protected]
336-713-4098
Majid Mirzazadeh, MD (PRINCIPAL_INVESTIGATOR)

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Wake Forest Health Sciences· Winston-Salem, NC

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