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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227937
• Other study ID #: 2021-07-07
• Status: Recruiting
• Start date: September 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Maimonides Medical Center
• Contact: Reuben Strayer, MD
• Phone: 718-283-6000
• Email: rstrayer[@]maimonidesmed.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystitis
• Urinary Tract Infections

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antonios Likourezos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of Urinary Tract Infection Symptoms	>80% of patients treated with amikacin will have resolution of urinary tract infection symptoms.	3 days (72 hours)