Bacteriophage Therapy in Patients With Urinary Tract Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2023-02-28

Brief Summary

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

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Detailed Description

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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

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Urinary Tract Infection Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Initially, patients with neurogenic bladder and urinary tract infections will be enrolled and followed for bacterial eradication. Results from this cohort will be used to confirm or modify the phage dosing regimen before proceeding to the patients with symptomatic infection at risk of recurrence. The trial will use pre-specified criteria to determine what phage regimens should be evaluated.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Patient will be randomized to receive either active phage or placebo treatment.

Study Groups

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Intravenous (IV)

Phage administered via the intravenous route.

Group Type EXPERIMENTAL