Single Dose Aminoglycosides for Acute Uncomplicated Cystitis in the Emergency Department Setting

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mercy Health Ohio
• Collaborator: Northeast Ohio Medical University
• Treatments: Cefdinir; Cephalexin; Gentamicins; Nitrofurantoin; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• At least 18 years of age, woman, pre-menopausal, non-pregnant with clinical signs of urinary tract infection and nitrite positive urine.

Exclusion Criteria:

• 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.