Single dose of amikacin for treating uncomplicated cystitis in the emergency department
Official title: Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study
Run by Maimonides Medical Center · NCT05227937 · Data updated 2026-11-12
This study tests if a single injection of the antibiotic amikacin can effectively treat uncomplicated bladder infections in women visiting the emergency department.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 14 Years to 110 Years |
| Sex | Women only |
| Enrollment | 75 (estimated) |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Status | Recruiting |
| Started | September 21, 2022 |
| Main results expected | May 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT05227937 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 14 and older with uncomplicated urinary tract infections and nitrite-positive urine.
✕Probably not a fit
Patients who are pregnant, have abnormal genitourinary tracts, or require hospitalization will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the feasibility of using a single dose of amikacin, an antibiotic, to treat patients with uncomplicated cystitis in the emergency department. Participants will receive either an intramuscular or intravenous injection of amikacin instead of a traditional multi-day oral antibiotic regimen. The study will enroll 75 female patients aged 14 and older who present with nitrite-positive urine and primary urinary complaints. Follow-up assessments will be conducted at 3, 7, and 30 days to monitor symptom resolution and any new symptoms.
Why it matters
Potential benefit: If successful, this approach could simplify treatment for urinary tract infections, reducing the need for multiple days of oral antibiotics.
How similar studies have gone: Previous studies have shown that single-dose amikacin is safe and effective for similar conditions, suggesting a promising approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Maimonides Medical Center
Brooklyn, New York, United States Recruiting
Study contacts
- Principal investigator: Reuben Strayer, MD — Maimonides Medical Center
- Study coordinator: Reuben Strayer, MD
- Email: rstrayer@maimonidesmed.org
- Phone: 718-283-6000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.