Clinical trial NCT05227937: Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
Official title: Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Tract Infections
Keywords: urinary tract infections
amikacin
emergency medicine
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 75
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Medicine Female Patients age ≥14 years of age with a primary urinary complaint.

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).

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.

Primary outcomes:
measure: Resolution of Urinary Tract Infection Symptoms
timeFrame: 3 days (72 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Reuben Strayer, MD
role: PRINCIPAL_INVESTIGATOR
References: