Clinical trial NCT04287478: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Urinary Tract Infection Bacterial
Keywords: Antimicrobial Resistance
Bacteriophage
Urinary Tract Infections
Phage
Lead sponsor: Adaptive Phage Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2020-02-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Identify ideal bacteriophage treatment regimens based on improvements in disease control rates
timeFrame: baseline
Secondary outcomes:
measure: Assess the safety of bacteriophage therapy
timeFrame: At least 56 days
measure: Assess the tolerability of bacteriophage therapy
timeFrame: At least 56 days
Other outcomes:
measure: Recurrence of urinary tract infection
timeFrame: 1 year
Locations:
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Miami Gardens
country: United States
facility: AMPM Research Clinic
state: Florida
city: Miami
country: United States
facility: AdMed Research
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center, Inc
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development
state: Texas
Study officials:
affiliation: Chief Medical Officer
name: Robert J Hopkins, MD
role: PRINCIPAL_INVESTIGATOR
References: