Bacteriophage Therapy in Patients With Urinary Tract Infections

Phase 1

Terminated

• Conditions: Urinary Tract Infection Bacterial
• Interventions: Biological: Bacteriophage Therapy

• Registration Number: NCT04287478
• Lead Sponsor: Adaptive Phage Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Study Start: 2020-12-09
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Subcohort B	Bacteriophage Therapy	Selected phage for Klebsiella pneumoniae administered via selected route based on previous Arms.
Intravesical (IVS)	Bacteriophage Therapy	Phage administered via the intravesical route.
Subcohort A	Bacteriophage Therapy	Selected phage for E. coli administered via selected route based on previous Arms.
Subcohort C	Bacteriophage Therapy	Selected phage for E. coli administered via selected route based on previous Arms.
Intravenous (IV)	Bacteriophage Therapy	Phage administered via the intravenous route.
Subcohort D	Bacteriophage Therapy	Selected phage for Klebsiella pneumoniae administered via selected route based on previous arms.

Primary Outcome Measures

Name	Time	Method
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates	baseline	Microbiological eradication of target pathogen identified at baseline

Secondary Outcome Measures

Name	Time	Method
Assess the tolerability of bacteriophage therapy	At least 56 days	Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events
Assess the safety of bacteriophage therapy	At least 56 days	Safety will be measured by the number and percent of treatment related adverse events.

Trial Locations

Locations (8)

AMPM Research Clinic; 🇺🇸 Miami Gardens, Florida, United States

Universal Axon Clinical Research; 🇺🇸 Doral, Florida, United States

Innovation Medical Research Center, Inc; 🇺🇸 Palmetto Bay, Florida, United States

AdMed Research; 🇺🇸 Miami, Florida, United States

James J. Peters VA Medical Center; 🇺🇸 Bronx, New York, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

DHR Health Institute for Research and Development; 🇺🇸 Edinburg, Texas, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States