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

Recruiting now

Conditions studied: Urinary Tract Infections

In brief

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.

Key facts

Study ID: NCT05227937
Run by: Antonios Likourezos
People needed: 75
Starts: 2022-09-21
Expected to finish: 2026-12-31
Last updated by the study team: 2026-03-04

Who can join

Age: 14 and older, up to 110. Sex: female. Healthy volunteers: accepted.

You may qualify if…

female emergency medicine patients
≥14 years of age
uncomplicated urinary tract infection
a primary urinary complaint and nitrite-positive urine.

You may not qualify if…

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.

Where it is running

Maimonides Medical Center — Brooklyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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