RecruitingNCT05227937

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

Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study

Sponsor

Antonios Likourezos

Enrollment

75 participants

Start Date

Sep 21, 2022

Study Type

OBSERVATIONAL

Conditions

Urinary Tract Infections

Summary

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.

Eligibility

Sex: FEMALEMin Age: 14 YearsMax Age: 110 Years

Inclusion Criteria4

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

Exclusion Criteria10

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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Interventions

DRUGAmikacin

patient will be treated with amikacin 15 mg/kg IV or IM, based on actual body weight; for patients \>120% of IBW, we will use AdjBW (IBW + 0.4(ABW-IBW)) rounded to nearest 50 mg. Patients who already have an IV will receive the medication IV, otherwise the dose will be given IM.