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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - female emergency medicine patients - ≥14 years of age - uncomplicated urinary tract infection - a primary urinary complaint and nitrite-positive urine. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Amikacin

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.

Locations (1)

Maimonides Medical Center
Brooklyn, New York, United States