Bacteriophage Therapy in Patients With Urinary Tract Infections

Urinary Tract Infection Bacterial Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04287478
• Other study ID #: APT.UTI.001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 9, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Adaptive Phage Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections
• Urinary Tract Infection Bacterial
• Urinary Tract Infections

Intervention

Biological:
• Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	Bronx	New York
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Universal Axon Clinical Research	Doral	Florida
United States	DHR Health Institute for Research and Development	Edinburg	Texas
United States	AdMed Research	Miami	Florida
United States	AMPM Research Clinic	Miami Gardens	Florida
United States	Innovation Medical Research Center, Inc	Palmetto Bay	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Adaptive Phage Therapeutics, Inc.	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrence of urinary tract infection	Recurrence of urinary tract infection for 1 year	1 year
Primary	Identify ideal bacteriophage treatment regimens based on improvements in disease control rates	Microbiological eradication of target pathogen identified at baseline	baseline
Secondary	Assess the safety of bacteriophage therapy	Safety will be measured by the number and percent of treatment related adverse events.	At least 56 days
Secondary	Assess the tolerability of bacteriophage therapy	Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events	At least 56 days