RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study

Quick Facts

Study Start:2022-09-21
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05227937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 110 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * female emergency medicine patients
  2. * ≥14 years of age
  3. * uncomplicated urinary tract infection
  4. * a primary urinary complaint and nitrite-positive urine.
  1. * pregnancy
  2. * abnormal genitourinary tract
  3. * recent urinary tract instrumentation
  4. * immunosuppression
  5. * CrCl \< 25 mL/min
  6. * evidence of pyelonephritis or sepsis
  7. * any antibiotic treatment within 30 days
  8. * not available for phone follow-up in 3, 7, and 30 days
  9. * requires admission to the hospital
  10. * abnormal mental status.

Contacts and Locations

Study Contact

Reuben Strayer, MD
CONTACT
718-283-6000
rstrayer@maimonidesmed.org
Antonios Likourezos, MA, MPH
CONTACT
718-283-6896
alikourezos@maimonidesmed.org

Principal Investigator

Reuben Strayer, MD
PRINCIPAL_INVESTIGATOR
Maimonides Medical Center

Study Locations (Sites)

Maimonides Medical Center
Brooklyn, New York, 11219
United States

Collaborators and Investigators

Sponsor: Antonios Likourezos

  • Reuben Strayer, MD, PRINCIPAL_INVESTIGATOR, Maimonides Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-21
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-09-21
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • urinary tract infections
  • amikacin
  • emergency medicine

Additional Relevant MeSH Terms

  • Urinary Tract Infections