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Antibiotic

Next Generation Sequencing for Urinary Tract Infections

Phase 4
Recruiting
Led By Majid Mirzazadeh, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female 18 to 80 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks post-treatment
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial is testing if a new urine test is more accurate than the current one.

Who is the study for?
This trial is for women aged 18 to 80 with a urinary tract infection (UTI) that's hard to detect using standard tests. They must be able to consent, follow the study schedule, and have low levels of bacteria in their urine. It's not for those who use catheters, can't give a clean urine sample, are pregnant or trying to conceive, incarcerated, or took antibiotics recently.
What is being tested?
The trial is testing how well advanced DNA techniques like PCR and Next Generation Sequencing can identify UTI-causing bacteria compared to traditional methods. These new tests could be more sensitive for detecting low-level infections in patients.
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications or treatments directly administered to participants, there may not be direct side effects from the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 80.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
Secondary study objectives
Urinary tract infection

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Symptomatic Patients with low Colony CountExperimental Treatment2 Interventions
Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \<10,000 to be treated based on Next Generation Sequencing result.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antibiotic
2008
Completed Phase 4
~6180

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,235 Total Patients Enrolled
Majid Mirzazadeh, MDPrincipal InvestigatorWake Forest Health Sciences
1 Previous Clinical Trials
4 Total Patients Enrolled

Media Library

Antibiotic (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05206500 — Phase 4
Urinary Tract Infection Research Study Groups: Symptomatic Patients with low Colony Count
Urinary Tract Infection Clinical Trial 2023: Antibiotic Highlights & Side Effects. Trial Name: NCT05206500 — Phase 4
Antibiotic (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206500 — Phase 4
~26 spots leftby Dec 2025
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