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

he study is a prospective open-label cohort study that seeks to enroll 75 ED patients diagnosed with uncomplicated cystitis. Enrolled patients will be treated with a single dose of amikacin. The primary endpoint is clinical cure at 3 days. We chose a non-comparative design as our treatment strategy is literature- and guideline- supported; our goal is demonstrate that it is feasible to execute this approach out of the emergency department. Urine culture is not recommended in the in the initial management of patients with uncomplicated UTI treated in emergency or primary care settings.3

Data Collection Procedures: Patients will be enrolled as a convenience sample by the research team. The investigators will determine eligibility, approach the ED clinical team, then approach and consent the patient.

If consented, 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.

The study measurements at enrollment are age, PMH, meds, allergies, symptoms, and symptom duration as well as urinalysis results, amikacin dose and route. Telephone follow-up at 3, 7, and 30 days will include the following data points: symptom resolution: (complete resolution / mostly better / a little better / same / worse); any new symptoms; any provider visits since index visit (if any visits, describe).

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.