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Bacteriophage Therapy in Patients With Urinary Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04287478
Recruitment Status : Active, not recruiting
First Posted : February 27, 2020
Last Update Posted : October 27, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Adaptive Phage Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Bacterial Biological: Bacteriophage Therapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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.
Primary Purpose: Treatment
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
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Identify ideal bacteriophage treatment regimens based on improvements in disease control rates [ Time Frame: baseline ]
    Microbiological eradication of target pathogen identified at baseline


Secondary Outcome Measures :
  1. 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.

  2. 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


Other Outcome Measures:
  1. Recurrence of urinary tract infection [ Time Frame: 1 year ]
    Recurrence of urinary tract infection for 1 year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287478


Locations
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United States, Florida
Universal Axon Clinical Research
Doral, Florida, United States, 33166
AMPM Research Clinic
Miami Gardens, Florida, United States, 33169
AdMed Research
Miami, Florida, United States, 33176
Innovation Medical Research Center, Inc
Palmetto Bay, Florida, United States, 33157
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New York
James J. Peters VA Medical Center
Bronx, New York, United States, 10468
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
DHR Health Institute for Research and Development
Edinburg, Texas, United States, 78539
Sponsors and Collaborators
Adaptive Phage Therapeutics, Inc.
United States Department of Defense
Investigators
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Principal Investigator: Robert J Hopkins, MD Chief Medical Officer
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Responsible Party: Adaptive Phage Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04287478    
Other Study ID Numbers: APT.UTI.001
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaptive Phage Therapeutics, Inc.:
Antimicrobial Resistance
Bacteriophage
Urinary Tract Infections
Phage
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Bacterial Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Bacterial Infections and Mycoses