search
Back to results

Bacteriophage Therapy in Patients With Urinary Tract Infections

Primary Purpose

Urinary Tract Infection Bacterial

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bacteriophage Therapy
Sponsored by
Adaptive Phage Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection Bacterial focused on measuring Antimicrobial Resistance, Bacteriophage, Urinary Tract Infections, Phage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universal Axon Clinical Research
  • AMPM Research Clinic
  • AdMed Research
  • Innovation Medical Research Center, Inc
  • Henry Ford Hospital
  • James J. Peters VA Medical Center
  • University of Texas Southwestern Medical Center
  • DHR Health Institute for Research and Development

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Intravenous (IV)

Intravesical (IVS)

Subcohort A

Subcohort B

Subcohort C

Subcohort D

Arm Description

Phage administered via the intravenous route.

Phage administered via the intravesical route.

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess the safety of bacteriophage therapy
Safety will be measured by the number and percent of treatment related adverse events.
Assess the tolerability of bacteriophage therapy
Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events

Full Information

First Posted
February 3, 2020
Last Updated
March 1, 2023
Sponsor
Adaptive Phage Therapeutics, Inc.
Collaborators
United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT04287478
Brief Title
Bacteriophage Therapy in Patients With Urinary Tract Infections
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to a change in development strategy.
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adaptive Phage Therapeutics, Inc.
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection Bacterial
Keywords
Antimicrobial Resistance, Bacteriophage, Urinary Tract Infections, Phage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Patient will be randomized to receive either active phage or placebo treatment.
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous (IV)
Arm Type
Experimental
Arm Description
Phage administered via the intravenous route.
Arm Title
Intravesical (IVS)
Arm Type
Experimental
Arm Description
Phage administered via the intravesical route.
Arm Title
Subcohort A
Arm Type
Experimental
Arm Description
Selected phage for E. coli administered via selected route based on previous Arms.
Arm Title
Subcohort B
Arm Type
Experimental
Arm Description
Selected phage for Klebsiella pneumoniae administered via selected route based on previous Arms.
Arm Title
Subcohort C
Arm Type
Experimental
Arm Description
Selected phage for E. coli administered via selected route based on previous Arms.
Arm Title
Subcohort D
Arm Type
Experimental
Arm Description
Selected phage for Klebsiella pneumoniae administered via selected route based on previous arms.
Intervention Type
Biological
Intervention Name(s)
Bacteriophage Therapy
Intervention Description
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Primary Outcome Measure Information:
Title
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates
Description
Microbiological eradication of target pathogen identified at baseline
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Assess the safety of bacteriophage therapy
Description
Safety will be measured by the number and percent of treatment related adverse events.
Time Frame
At least 56 days
Title
Assess the tolerability of bacteriophage therapy
Description
Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events
Time Frame
At least 56 days
Other Pre-specified Outcome Measures:
Title
Recurrence of urinary tract infection
Description
Recurrence of urinary tract infection for 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Hopkins, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universal Axon Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
AMPM Research Clinic
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
AdMed Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Innovation Medical Research Center, Inc
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
DHR Health Institute for Research and Development
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bacteriophage Therapy in Patients With Urinary Tract Infections

We'll reach out to this number within 24 hrs