Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amikacin.
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections. Basic parameters: 14 years — 110 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study
Overview
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).
Interventions
- 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.
Primary outcome measures
- Resolution of Urinary Tract Infection Symptoms [Time frame: 3 days (72 hours)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Maimonides Medical Center — Brooklyn
Identifiers
NCT: NCT05227937 · 2021-07-07