NCT05227937

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

January 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

January 27, 2022

Last Update Submit

March 2, 2026

Conditions

Urinary Tract Infections

Keywords

urinary tract infectionsamikacinemergency medicine

Outcome Measures

Primary Outcomes (1)

  • Resolution of Urinary Tract Infection Symptoms

    \>80% of patients treated with amikacin will have resolution of urinary tract infection symptoms.

    3 days (72 hours)

Study Arms (1)

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.

Drug: Amikacin

Interventions

AmikacinDRUG

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.

Single Dose Amikacin

Eligibility Criteria

Age14 Years - 110 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency Medicine Female Patients age ≥14 years of age with a primary urinary complaint.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Amikacin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

KanamycinAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Reuben Strayer, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reuben Strayer, MD

CONTACT

718-283-6000rstrayer@maimonidesmed.org

Antonios Likourezos, MA, MPH

CONTACT

718-283-6896alikourezos@maimonidesmed.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Administration Director

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 8, 2022

Study Start

September 21, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)