Bacteriophage Therapy in Patients With Urinary Tract Infections

NCT04287478 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: APT.UTI.001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Urinary Tract Infection Bacterial

Keywords

Antimicrobial Resistance; Bacteriophage; Urinary Tract Infections; Phage

Outcome Measures

Primary Outcomes (1)

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

  Microbiological eradication of target pathogen identified at baseline

  baseline

Secondary Outcomes (2)

• Assess the safety of bacteriophage therapy

  At least 56 days

• Assess the tolerability of bacteriophage therapy

  At least 56 days

Other Outcomes (1)

• Recurrence of urinary tract infection

  1 year

Study Arms (6)

Intravenous (IV)

EXPERIMENTAL

Phage administered via the intravenous route.

Biological: Bacteriophage Therapy

Intravesical (IVS)

EXPERIMENTAL

Phage administered via the intravesical route.

Biological: Bacteriophage Therapy

Subcohort A

EXPERIMENTAL

Selected phage for E. coli administered via selected route based on previous Arms.

Biological: Bacteriophage Therapy

Subcohort B

EXPERIMENTAL

Selected phage for Klebsiella pneumoniae administered via selected route based on previous Arms.

Biological: Bacteriophage Therapy

Subcohort C

EXPERIMENTAL

Selected phage for E. coli administered via selected route based on previous Arms.

Biological: Bacteriophage Therapy

Subcohort D

EXPERIMENTAL

Selected phage for Klebsiella pneumoniae administered via selected route based on previous arms.

Biological: Bacteriophage Therapy

Interventions

Bacteriophage Therapy BIOLOGICAL

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

Intravenous (IV); Intravesical (IVS); Subcohort A; Subcohort B; Subcohort C; Subcohort D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adaptive Phage Therapeutics, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (8)

Universal Axon Clinical Research

Doral, Florida, 33166, United States

Location

AdMed Research

Miami, Florida, 33176, United States

Location

AMPM Research Clinic

Miami Gardens, Florida, 33169, United States

Location

Innovation Medical Research Center, Inc

Palmetto Bay, Florida, 33157, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

DHR Health Institute for Research and Development

Edinburg, Texas, 78539, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Phage Therapy

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Robert J Hopkins, MD

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patient will be randomized to receive either active phage or placebo treatment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 27, 2020
• Study Start: December 9, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (8)