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

ConditionUrinary Tract Infections

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age14-110

SponsorAntonios Likourezos

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

female emergency medicine patients

≥14 years of age

uncomplicated urinary tract infection

a primary urinary complaint and nitrite-positive urine.

Disqualifiers

pregnancy

abnormal genitourinary tract

recent urinary tract instrumentation

immunosuppression

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Amikacin
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.

Treatment groups

75 Participants

are divided into 1 treatment group

Group A: Single Dose Amikacin1 intervention

Trial outcomes

Primary outcomes

Resolution of Urinary Tract Infection Symptoms

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

Time frame

3 days (72 hours)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Antonios Likourezos

Lead sponsor

Maimonides Medical Center

Sponsor institution

Source ClinicalTrials.gov

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