Bacteriophage Therapy in Patients With Urinary Tract Infections

March 1, 2023 updated by: Adaptive Phage Therapeutics, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Doral, Florida, United States, 33166
        • Universal Axon Clinical Research
      • Miami, Florida, United States, 33176
        • Admed Research
      • Miami Gardens, Florida, United States, 33169
        • AMPM Research Clinic
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Medical Research Center, Inc
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • Bronx, New York, United States, 10468
        • James J. Peters VA Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Edinburg, Texas, United States, 78539
        • DHR Health Institute for Research and Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous (IV)
Phage administered via the intravenous route.
Biological: Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Experimental: Intravesical (IVS)
Phage administered via the intravesical route.
Biological: Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Experimental: Subcohort A
Selected phage for E. coli administered via selected route based on previous Arms.
Biological: Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Experimental: Subcohort B
Selected phage for Klebsiella pneumoniae administered via selected route based on previous Arms.
Biological: Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Experimental: Subcohort C
Selected phage for E. coli administered via selected route based on previous Arms.
Biological: Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Experimental: Subcohort D
Selected phage for Klebsiella pneumoniae administered via selected route based on previous arms.
Biological: Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates
Time Frame: baseline
Microbiological eradication of target pathogen identified at baseline
baseline

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of urinary tract infection
Time Frame: 1 year
Recurrence of urinary tract infection for 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adaptive Phage Therapeutics, Inc.

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Robert J Hopkins, MD, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2020

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APT.UTI.001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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