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GIVEIT: Gentamicin for Post-op UTI
NCT04246996Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2020
- Primary completion
- Dec 2021
- Countries
- 1
- Sponsor
- Kaiser Permanente
- Modality
- Nanoparticles, Implantable Devices, Transdermal Patches
- Drugs
- gentamicin
- Conditions
- urinary tract infection (UTI)
01
Overview
Phase 2, randomised, single-blind trial of gentamicin in urinary tract infection (UTI) (2 arms), sponsored by Kaiser Permanente. Primary endpoint: Post-operative Urinary Tract Infection at 6 weeks. Started Jan 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Gentamicin Arm
80mg Gentamicin in 50mL saline intravesical instillation, clamped for 1 hour
Control Arm
Catheter clamping only for 1 hour (Sham)
03
Endpoints
Primary
Post-operative Urinary Tract Infection
Secondary
Adverse Events
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
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