Single Dose Aminoglycosides for Acute Uncomplicated Cystitis in the Emergency Department Setting
1 other identifier
interventional
160
1 country
1
Brief Summary
The purpose of this research study is to determine if gentamicin is as effective treatment of acute uncomplicated cystitis (urinary tract infection) using aminoglycosides versus the current standards of care. The current standards of care in our region are often to prescribe a multi-day antibiotic prescription that is taken multiple times per day whereas gentamicin will be a one-time dose in the emergency department. Gentamicin is the medicine being studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJanuary 27, 2023
January 1, 2023
9 months
September 22, 2022
January 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Resolution
If patient is or is not still having any pain with urination, urinary frequency or urinary urgency
7 days from presentation
Clinical Resolution
If patient is or is not still having any pain with urination, urinary frequency or urinary urgency
30 days from presentation
Study Arms (2)
Gentamicin
ACTIVE COMPARATORSubjects 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).
Standard of Care
ACTIVE COMPARATOROral antibiotic prescription
Interventions
Usual oral antibiotic multi-day dosing based on local antibiogram
Eligibility Criteria
You may qualify if:
- At least 18 years of age, woman, pre-menopausal, non-pregnant with clinical signs of urinary tract infection and nitrite positive urine.
You may not qualify if:
- Contraindications include hypersensitivity to gentamicin or other aminoglycosides.
- Patients younger than 18 years of age.
- Pregnant or post-menopausal patients.
- Patients without symptoms of UTI, nitrite negative urine, or any patient with working diagnosis of complicated UTI such as pyelonephritis or any patient catheterized.
- ANY history of pre-existing renal impairment.
- Patient that has any listed or reports taking ANY nephrotoxic or wit drug-drug interaction medication in the past 7 days (see Appendix 5).
- ANY history of hearing loss, tinnitus, or vertigo.
- ANY patient that has received general anesthesia or neuromuscular blockade in past 7 days.
- Patients with ANY history of neuromuscular disorders including: myasthenia gravis, amyotrophic lateral sclerosis, muscular dystrophy, botulism, congenital myasthenic syndromes, congenital myopathies, myositis, Lambert-Eaton syndrome, mitochondrial myopathy, myotonic dystrophy, neuromyotonia, or peripheral neuropathy.
- Patients with ANY history of thrombocytopenia.
- Patient that has any listed or reports taking ANY anticoagulants in the past 7 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mercy Health Ohiolead
- Northeast Ohio Medical Universitycollaborator
Study Sites (1)
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
Related Publications (6)
Goodlet KJ, Benhalima FZ, Nailor MD. A Systematic Review of Single-Dose Aminoglycoside Therapy for Urinary Tract Infection: Is It Time To Resurrect an Old Strategy? Antimicrob Agents Chemother. 2018 Dec 21;63(1):e02165-18. doi: 10.1128/AAC.02165-18. Print 2019 Jan.
PMID: 30397061BACKGROUNDDurkin MJ, Keller M, Butler AM, Kwon JH, Dubberke ER, Miller AC, Polgreen PM, Olsen MA. An Assessment of Inappropriate Antibiotic Use and Guideline Adherence for Uncomplicated Urinary Tract Infections. Open Forum Infect Dis. 2018 Aug 10;5(9):ofy198. doi: 10.1093/ofid/ofy198. eCollection 2018 Sep.
PMID: 30191156BACKGROUNDAbabneh M, Harpe S, Oinonen M, Polk RE. Trends in aminoglycoside use and gentamicin-resistant gram-negative clinical isolates in US academic medical centers: implications for antimicrobial stewardship. Infect Control Hosp Epidemiol. 2012 Jun;33(6):594-601. doi: 10.1086/665724. Epub 2012 Apr 19.
PMID: 22561715BACKGROUNDFoxman B. The epidemiology of urinary tract infection. Nat Rev Urol. 2010 Dec;7(12):653-60. doi: 10.1038/nrurol.2010.190.
PMID: 21139641BACKGROUNDKang CI, Kim J, Park DW, Kim BN, Ha US, Lee SJ, Yeo JK, Min SK, Lee H, Wie SH. Clinical Practice Guidelines for the Antibiotic Treatment of Community-Acquired Urinary Tract Infections. Infect Chemother. 2018 Mar;50(1):67-100. doi: 10.3947/ic.2018.50.1.67.
PMID: 29637759BACKGROUNDSanchez GV, Babiker A, Master RN, Luu T, Mathur A, Bordon J. Antibiotic Resistance among Urinary Isolates from Female Outpatients in the United States in 2003 and 2012. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2680-3. doi: 10.1128/AAC.02897-15. Print 2016 May.
PMID: 26883714BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2022
First Posted
January 27, 2023
Study Start
October 1, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2024
Last Updated
January 27, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share