Recruiting

Amikacin

Sponsor:

Antonios Likourezos

Code:

NCT05227937

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: Female

Age: 14 - 70+

Healthy Volunteers: Accepted

Interventions

Amikacin

Study Details

Brief 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.

Conditions

Urinary Tract Infections

Study ID

NCT05227937

Start date

Sep 21, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Resolution of Urinary Tract Infection Symptoms [ Time Frame: 3 days (72 hours) ]

Central Contacts and Locations

Central contacts

Reuben Strayer, MD

718-283-6000rstrayer@maimonidesmed.org

Antonios Likourezos, MA, MPH

718-283-6896alikourezos@maimonidesmed.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Reuben Strayer, MD

rstrayer@maimonidesmed.org

Antonios Likourezos, MA, MPH

alikourezos@maimonidesmed.org

More Information

Sponsor

Antonios Likourezos

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • urinary tract infections
  • amikacin
  • emergency medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Antonios Likourezos on 2026-03-04.