Clinical trial

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

Name

2021-07-07

Description

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.

Trial arms

Trial start

2022-09-21

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Recruiting

Treatment

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.

Arms:

Single Dose Amikacin

Size

Primary endpoint

Resolution of Urinary Tract Infection Symptoms

3 days (72 hours)

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

Updated at

2023-09-21

1 organization

1 product

1 indication

Organization

Antonios Likourezos

Product

Amikacin

Indication

Urinary Tract Infections