drugset / Trial / NCT05702762
Single Dose Aminoglycosides for Acute Uncomplicated Cystitis in the Emergency Department Setting
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-10-01
- Primary completion
- 2023-06-30
- Completion
- 2024-06-30
Publications
- Background 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.
- Background Durkin 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.
- Background Ababneh 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.
- Background Foxman B. The epidemiology of urinary tract infection. Nat Rev Urol. 2010 Dec;7(12):653-60. doi: 10.1038/nrurol.2010.190.
- Background Kang 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.
- Background Sanchez 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gentamicin | Small molecule | 5 mg/kg | Intramuscular |
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | — | Oral |
| Comparator | Nitrofurantoin | Unknown | — | Oral |
| Comparator | Sulfamethoxazole | Small molecule | — | Oral |
| Comparator | Trimethoprim | Small molecule | — | Oral |
| Comparator | cefdinir | Other / unclassified | — | Oral |