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

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.

Conditions

Urinary Tract Infections

Study Overview

Study Details

Study overview

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.

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

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

Condition
Urinary Tract Infections
Intervention / Treatment

-

Contacts and Locations

Brooklyn

Maimonides Medical Center, Brooklyn, New York, United States, 11219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

14 Years to 110 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Antonios Likourezos,

Reuben Strayer, MD, PRINCIPAL_INVESTIGATOR, Maimonides Medical Center

Study Record Dates

2024-12-31