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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 14
Maximum Age: 110
Healthy Volunteers: t
View:

• female emergency medicine patients

• ≥14 years of age

• uncomplicated urinary tract infection

• a primary urinary complaint and nitrite-positive urine.

Locations
United States
New York
Maimonides Medical Center
RECRUITING
Brooklyn
Contact Information
Primary
Reuben Strayer, MD
rstrayer@maimonidesmed.org
718-283-6000
Backup
Antonios Likourezos, MA, MPH
alikourezos@maimonidesmed.org
718-283-6896
Time Frame
Start Date: 2022-09-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 75
Treatments
Single Dose 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.
Related Therapeutic Areas
Sponsors
Leads: Antonios Likourezos

This content was sourced from clinicaltrials.gov