Bacteriophage Therapy in Patients With Urinary Tract Infections

Phase 2TerminatedNCT04287478

Adaptive Phage Therapeutics, Inc.1 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Tract Infection Bacterial

Interventions

Bacteriophage TherapyBIOLOGICAL

Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

General Inclusion Criteria: * Males or females ≥18 years of age. * Female patients of childbearing potential. * Male patients must agree not to donate sperm up for one month. * English-speaking. General Exclusion Criteria: * Stage 4 or greater chronic kidney disease (CKD). * Abnormal liver function tests \>3×upper limit of normal (ULN). * Other conditions which could confound study results. * Body mass index of \> 40 or weight less than 50 kg. * Known allergy to phage products. * Pregnant and/or breastfeeding. * Immunocompromised. * Need for antiviral medication. * History of severe autonomic dysreflexia.

Locations (8)

Universal Axon Clinical Research

Doral, Florida, United States

AdMed Research

Miami, Florida, United States

AMPM Research Clinic

Miami Gardens, Florida, United States

Innovation Medical Research Center, Inc

Palmetto Bay, Florida, United States

Outcomes

Primary Outcomes

Identify ideal bacteriophage treatment regimens based on improvements in disease control rates

Microbiological eradication of target pathogen identified at baseline

Time frame: baseline

Secondary Outcomes

Assess the safety of bacteriophage therapy

Safety will be measured by the number and percent of treatment related adverse events.

Time frame: At least 56 days

Assess the tolerability of bacteriophage therapy

Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events

Time frame: At least 56 days

Data from ClinicalTrials.gov

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