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Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury

NCT03503513 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-06-25

Study results available
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Summary

A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.

Conditions

Interventions

DRUG

Gentamicin Sulfate

Gentamicin is compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Pharmacy mails participants treatment drug. Once received, participants will do daily instillations of 30 milliliters of solution after catheterizing their bladder at night.

Sponsors & Collaborators

Principal Investigators

  • Denise G Tate, PhD · University of Michigan

  • Anne Pelletier-Cameron, MD · University of Michigan

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-24
Primary Completion
2023-09-08
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503513 on ClinicalTrials.gov