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Antibiotic

Next Generation Sequencing for Urinary Tract Infections

Q: Has this remedy obtained official authorization from the Food and Drug Administration?

The safety of this treatment is highly assured, receiving a score of 3 due to the standards that must be met for Phase 4 trials in order for them to receive approval.

Q: Are recruitment efforts still underway for this research project?

Affirmatively, the clinical trial is currently recruiting participants. According to records on clinicaltrials.gov, this study was originally published on May 17th 2022 and underwent its most recent revision on February 27th 2023.

Q: What is the total number of participants in this trial?

Affirmative, clinicaltrials.gov has records which suggest that this medical experiment is presently recruiting participants. This trial was first posted on May 17th 2022 and underwent its most recent amendments on February 27th 2023. The study requires 100 volunteers to be recruited from one site.

Q: Are seniors aged 85 and above eligible to enter this clinical trial?

This medical trial seeks to enroll participants between the ages of 18 and 80. Separately, there are 23 trials for those under 18 years of age and 67 clinical studies available for patients over 65.

Q: How can I register to participate in this experiment?

To be eligible for inclusion in this trial, participants must possess a urinary tract infection and have an age between 18 to 80 years. There are slots available for 100 patients.

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)

Secondary outcome measures

Urinary tract infection

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

~3070

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,167 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this remedy obtained official authorization from the Food and Drug Administration?

"The safety of this treatment is highly assured, receiving a score of 3 due to the standards that must be met for Phase 4 trials in order for them to receive approval."

Answered by AI

Are recruitment efforts still underway for this research project?

"Affirmatively, the clinical trial is currently recruiting participants. According to records on clinicaltrials.gov, this study was originally published on May 17th 2022 and underwent its most recent revision on February 27th 2023."

Answered by AI

What is the total number of participants in this trial?

"Affirmative, clinicaltrials.gov has records which suggest that this medical experiment is presently recruiting participants. This trial was first posted on May 17th 2022 and underwent its most recent amendments on February 27th 2023. The study requires 100 volunteers to be recruited from one site."

Answered by AI

Are seniors aged 85 and above eligible to enter this clinical trial?

"This medical trial seeks to enroll participants between the ages of 18 and 80. Separately, there are 23 trials for those under 18 years of age and 67 clinical studies available for patients over 65."

Answered by AI

How can I register to participate in this experiment?

"To be eligible for inclusion in this trial, participants must possess a urinary tract infection and have an age between 18 to 80 years. There are slots available for 100 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NextGen - Clinical Implication of Next Generation Sequencing

2022. "NextGen - Clinical Implication of Next Generation Sequencing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05206500.

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