Urinary Tract InfectionsNCT05227937
Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
An observational study of Urinary Tract Infections, run by Antonios Likourezos at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 110 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Amikacin
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 110 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Emergency Medicine Female Patients age ≥14 years of age with a primary urinary complaint.
Who may be able to join
- female emergency medicine patients
- ≥14 years of age
- uncomplicated urinary tract infection
- a primary urinary complaint and nitrite-positive urine.
Who cannot join
- pregnancy
- abnormal genitourinary tract
- recent urinary tract instrumentation
- immunosuppression
- CrCl < 25 mL/min
- evidence of pyelonephritis or sepsis
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Reuben Strayer, MD, rstrayer@maimonidesmed.org
Antonios Likourezos, MA, MPH, alikourezos@maimonidesmed.org
About this study
Official title: Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study
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.
Read the 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).
- Conditions
- Urinary Tract Infections
- Being tested
- Amikacin
- Keywords
- urinary tract infections, amikacin, emergency medicine
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose 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. Receives: Drug: Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Urinary Tract Infection Symptoms
>80% of patients treated with amikacin will have resolution of urinary tract infection symptoms.
Measured: 3 days (72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start21 Sep 2022
- Primary completion31 May 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Reuben Strayer, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227937
- Sponsor's protocol ID
- 2021-07-07
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study
- ClinicalTrials.gov ID
- NCT05227937
- Acronym / sponsor ID
- 2021-07-07
- Conditions
- Urinary Tract Infections
- Keywords
- urinary tract infections, amikacin, emergency medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Dose Amikacin | – | Drug: AmikacinPatient 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. |
Who may qualify
- Ages
- 14 to 110 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Emergency Medicine Female Patients age ≥14 years of age with a primary urinary complaint.
Key inclusion criteria (4 listed)
- female emergency medicine patients
- ≥14 years of age
- uncomplicated urinary tract infection
- a primary urinary complaint and nitrite-positive urine.
Key exclusion criteria (10 listed)
- pregnancy
- abnormal genitourinary tract
- recent urinary tract instrumentation
- immunosuppression
- CrCl < 25 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amikacinpatient 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. | Drug | Single Dose Amikacin |
Primary outcome
Resolution of Urinary Tract Infection Symptoms
Time frame: 3 days (72 hours)
>80% of patients treated with amikacin will have resolution of urinary tract infection symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reuben Strayer, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Antonios Likourezos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reuben Strayer, MD (718-283-6000, rstrayer@maimonidesmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Urinary Tract Infection Symptoms (time frame: 3 days (72 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.