Recruiting
Phase 2

Aminoglycosides

Sponsor:

Mercy Health Ohio

Code:

NCT05702762

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Gentamicin

Standard of Care

Study Details

Brief summary:

The purpose of this research study is to determine if gentamicin is as effective treatment of acute uncomplicated cystitis (urinary tract infection) using aminoglycosides versus the current standards of care. The current standards of care in our region are often to prescribe a multi-day antibiotic prescription that is taken multiple times per day whereas gentamicin will be a one-time dose in the emergency department. Gentamicin is the medicine being studied.

Conditions

Urinary Tract Infections

Study ID

NCT05702762

Start date

Oct 1, 2022

Status verified date

Jan, 2023

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • At least 18 years of age, woman, pre-menopausal, non-pregnant with clinical signs of urinary tract infection and nitrite positive urine.

Exclusion Criteria:

  • Contraindications include hypersensitivity to gentamicin or other aminoglycosides.
  • Patients younger than 18 years of age.
  • Pregnant or post-menopausal patients.
  • Patients without symptoms of UTI, nitrite negative urine, or any patient with working diagnosis of complicated UTI such as pyelonephritis or any patient catheterized.
  • ANY history of pre-existing renal impairment.
  • Patient that has any listed or reports taking ANY nephrotoxic or wit drug-drug interaction medication in the past 7 days (see Appendix 5).
  • ANY history of hearing loss, tinnitus, or vertigo.
  • ANY patient that has received general anesthesia or neuromuscular blockade in past 7 days.
  • Patients with ANY history of neuromuscular disorders including: myasthenia gravis, amyotrophic lateral sclerosis, muscular dystrophy, botulism, congenital myasthenic syndromes, congenital myopathies, myositis, Lambert-Eaton syndrome, mitochondrial myopathy, myotonic dystrophy, neuromyotonia, or peripheral neuropathy.
  • Patients with ANY history of thrombocytopenia.
  • Patient that has any listed or reports taking ANY anticoagulants in the past 7 days.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Gentamicin

Subjects will be given one (1) injection intramuscular gentamicin 5 mg/kg (actual body weight unless patient is >120% ideal body weight in which case adjusted body weight will be utilized).

active comparator: Standard of Care

Oral antibiotic prescription

Interventions

Gentamicin

5 mg/kg intramuscular injection

Standard of Care

Usual oral antibiotic multi-day dosing based on local antibiogram

Primary outcome measure

  • Clinical Resolution [ Time Frame: 7 days from presentation ]
  • Clinical Resolution [ Time Frame: 30 days from presentation ]

Central Contacts and Locations

Central contacts

Jacob Sieger, DO

6104571345jsieger@mercy.com

Vincent Peyko, PharmD

3307185919vjpeyko@mercy.com

Locations

St. Elizabeth Youngstown Hospital

Recruiting

Youngstown, Ohio, United States, 44501

Contacts

Joseph Dombroski, DO

330-272-4938joedombroski@gmail.com

More Information

Sponsor

Mercy Health Ohio

Last update posted

Jan 27, 2023

Last verified

Jan, 2023

Keywords

  • gentamicin
  • single dose antibiotic treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercy Health Ohio on 2023-01-27.