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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04287478
Recruitment Status : Recruiting
First Posted : February 27, 2020
Last Update Posted : December 7, 2021
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 : September 2022
Estimated Study Completion Date : September 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


Contacts
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Contact: Stephanie Holland 202-391-8058 sholland@aphage.com

Locations
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United States, Florida
Universal Axon Clinical Research Recruiting
Doral, Florida, United States, 33166
Contact: Gian Troche    305-677-9267 ext 17    gtroche@uaclinical.com   
Principal Investigator: Luis Martinez         
AMPM Research Clinic Not yet recruiting
Miami Gardens, Florida, United States, 33169
Contact: Laura Guillen         
Principal Investigator: Abel Murillo, MD         
AdMed Research Not yet recruiting
Miami, Florida, United States, 33176
Contact: Indiana Gonzalez    786-971-7625    igonzalez@admedresearch.com   
Principal Investigator: Ladynez Espinal, MD         
Innovation Medical Research Center, Inc Recruiting
Palmetto Bay, Florida, United States, 33157
Contact: Janelly Mainade    305-300-2695    jmainade@innovationmrc.com   
Principal Investigator: Karen Figueredo-Reyes, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Melissa Resk    313-916-7276    mresk1@hfhs.org   
Principal Investigator: Mayur Ramesh, MD         
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Johane Simelane, MPH       Johane.Simelane@va.gov   
Principal Investigator: Sheldon T Brown, MD         
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Donna Mitchell    214-645-8787    donna.mitchell@Utsouthwestern.edu   
Principal Investigator: Philippe Zimmern, MD         
DHR Health Institute for Research and Development Not yet recruiting
Edinburg, Texas, United States, 78539
Contact: Katelyn Villa    956-362-2391    k.villa@dhr-rgv.com   
Principal Investigator: Roberto Cruz Saldana, MD         
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: December 7, 2021
Last Verified: December 2021

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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