NCT05227937 Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
| NCT ID | NCT05227937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Antonios Likourezos |
| Condition | Urinary Tract Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2022-09-21 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2022-09-21 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Reuben Strayer, MD
PRINCIPAL INVESTIGATOR
Maimonides Medical Center
Frequently Asked Questions
Who can join the NCT05227937 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 110 Years, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05227937 currently recruiting?
Yes, NCT05227937 is actively recruiting participants. Contact the research team at rstrayer@maimonidesmed.org for enrollment information.
Where is the NCT05227937 trial being conducted?
This trial is being conducted at Brooklyn, United States.
Who is sponsoring the NCT05227937 clinical trial?
NCT05227937 is sponsored by Antonios Likourezos. The principal investigator is Reuben Strayer, MD at Maimonides Medical Center. The trial plans to enroll 75 participants.