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Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study

Recruitingn/aAges 14 Years - 110 YearsFemaleAntonios Likourezos
NCT05227937 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to determine if a single dose of amikacin (a type of antibiotic) can be used to effectively treat emergency department patients with uncomplicated cystitis (inflammation of the bladder). Participating in this study will allow the patient to treat their urinary tract infection (UTI) with a single intramuscular (IM (into the arm)) or intravenous (IV (into the vein)) shot of amikacin, rather than having to go to the pharmacy to pick up a prescription for antibiotics, and then take antibiotics for 3-7 days. A single dose of amikacin has been demonstrated to be safe, effective and well tolerated in other studies, but some patients may decline to participate because they do not wish to have an IV or IM shot, or because they don't want to speak on the phone with a research assistant three times over the next 30 days.

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📋 Eligibility rules (as published)
Inclusion Criteria: * female emergency medicine patients * ≥14 years of age * uncomplicated urinary tract infection * a primary urinary complaint and nitrite-positive urine. Exclusion Criteria: * pregnancy * abnormal genitourinary tract * recent urinary tract instrumentation * immunosuppression * CrCl \< 25 mL/min * evidence of pyelonephritis or sepsis * any antibiotic treatment within 30 days * not available for phone follow-up in 3, 7, and 30 days * requires admission to the hospital * abnormal mental status.
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What it tests

  • Amikacin
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Where

1 site
Maimonides Medical Center
Brooklyn, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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