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Aminoglycoside Antibiotic
Single Dose Gentamicin for Urinary Tract Infections
Phase 2
Recruiting
Research Sponsored by Mercy Health Ohio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days from presentation
Awards & highlights
Study Summary
This trial is testing if gentamicin can be as effective as current treatments for urinary tract infections in just one dose.
Who is the study for?
This trial is for pre-menopausal women over 18 who are not pregnant and show signs of a simple bladder infection with positive nitrite in urine. It's not for those with hearing issues, vertigo, kidney problems, recent anesthesia or muscle blockers, blood thinners use, or neuromuscular disorders.Check my eligibility
What is being tested?
The study tests if a single dose of Gentamicin in the emergency department can treat bladder infections as effectively as the standard multi-day antibiotic course that's usually prescribed.See study design
What are the potential side effects?
Gentamicin may cause side effects like hearing problems (including loss of hearing), ringing in the ears (tinnitus), dizziness due to inner ear issues (vertigo), and potential kidney damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days from presentation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days from presentation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Resolution
Trial Design
2Treatment groups
Active Control
Group I: GentamicinActive Control1 Intervention
Subjects will be given one (1) injection intramuscular gentamicin 5 mg/kg (actual body weight unless patient is >120% ideal body weight in which case adjusted body weight will be utilized).
Group II: Standard of CareActive Control1 Intervention
Oral antibiotic prescription
Find a Location
Who is running the clinical trial?
Mercy Health OhioLead Sponsor
14 Previous Clinical Trials
1,445 Total Patients Enrolled
Northeast Ohio Medical UniversityUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 years old.I have a history of neuromuscular disorders.I have experienced hearing loss, ringing in my ears, or dizziness.I do not have UTI symptoms, my urine test for nitrite was negative, or I have a complicated UTI diagnosis.I haven't taken any kidney-damaging medications in the last week.You are allergic to gentamicin or other similar antibiotics.I have a history of kidney problems.I have taken blood thinners in the last week.I have a history of low platelet counts.I am a woman over 18, not pregnant, pre-menopausal with signs of a UTI and a positive nitrite test.I am either pregnant or have gone through menopause.I have not been under general anesthesia or muscle relaxants in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Gentamicin
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects can be expected from Gentamicin utilization?
"Gentamicin's safety has been partially established and thus, it was awarded a score of 2 on our safety assessment scale. This is due to the fact that this drug is currently in Phase 2 clinical trials without any efficacy data yet available."
Answered by AI
What is the size of the population participating in this clinical investigation?
"Affirmative, according to the information provided on clinicaltrials.gov this research project is currently in need of new participants. It was first published on October 1st 2022 and has recently been updated on January 18th 2023. The study requires 160 volunteers from a single facility."
Answered by AI
Are recruitment efforts still underway for this experiment?
"Affirmative. Clinicaltrials.gov demonstrates that this medical research, which was first posted on October 1st 2022 is presently recruiting subjects. Around 160 people are needed to be enrolled from a single healthcare facility."
Answered by AI
Who else is applying?
What site did they apply to?
St. Elizabeth Youngstown Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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