NCT04287478

Bacteriophage Therapy in Patients With Urinary Tract Infections

A Phase I/II Study of Bacteriophage Therapy to Evaluate Safety, Tolerability, and Efficacy of Targeted "Personalized" Bacteriophage Treatments in Patients With Bacterial Infection of the Urinary Tract

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Adaptive Phage Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.

Detailed description

This study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (UTI). Patients to be enrolled will have urinary tract infections due to E. coli and K. pneumoniae. This will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of UTI recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection.

Conditions

• Urinary Tract Infection Bacterial

Interventions

Type	Name	Description
BIOLOGICAL	Bacteriophage Therapy	Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

Timeline

• Start date: 2020-12-09
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2020-02-27
• Last updated: 2023-03-03

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study