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

NCT ID: NCT05227937

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2025-12-31

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.

Detailed Description

he study is a prospective open-label cohort study that seeks to enroll 75 ED patients diagnosed with uncomplicated cystitis. Enrolled patients will be treated with a single dose of amikacin. The primary endpoint is clinical cure at 3 days. We chose a non-comparative design as our treatment strategy is literature- and guideline- supported; our goal is demonstrate that it is feasible to execute this approach out of the emergency department. Urine culture is not recommended in the in the initial management of patients with uncomplicated UTI treated in emergency or primary care settings.3

Data Collection Procedures: Patients will be enrolled as a convenience sample by the research team. The investigators will determine eligibility, approach the ED clinical team, then approach and consent the patient.

If consented, 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.

The study measurements at enrollment are age, PMH, meds, allergies, symptoms, and symptom duration as well as urinalysis results, amikacin dose and route. Telephone follow-up at 3, 7, and 30 days will include the following data points: symptom resolution: (complete resolution / mostly better / a little better / same / worse); any new symptoms; any provider visits since index visit (if any visits, describe).

Conditions

Urinary Tract Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Amikacin

Intervention Type: 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.

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Antonios Likourezos

OTHER

Sponsor Role: lead

Responsible Party

Antonios Likourezos

Research Administration Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Reuben Strayer, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Reuben Strayer, MD

Role: CONTACT

rstrayer@maimonidesmed.org

718-283-6000

Antonios Likourezos, MA, MPH

Role: CONTACT

alikourezos@maimonidesmed.org

718-283-6896

Facility Contacts

Reuben Strayer, MD

Role: primary

rstrayer@maimonidesmed.org

Antonios Likourezos, MA, MPH

Role: backup

alikourezos@maimonidesmed.org

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-07-07

Identifier Type: -

Identifier Source: org_study_id