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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Antonios Likourezos
Study ID
NCT05227937
Status
Recruiting
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Conditions

  • Urinary Tract Infections

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • Amikacin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 21, 2022
Status verified
Mar 2026
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maimonides Medical CenterBrooklynNew York11219
Reuben Strayer, MD
[email protected]
Antonios Likourezos, MA, MPH
[email protected]

Find similar trials in Brooklyn, NY

By research site
Maimonides Medical Center· Brooklyn, NY

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