Bacteriophage Therapy in Patients With Urinary Tract Infections
- Conditions
- Urinary Tract Infection Bacterial
- Registration Number
- NCT04287478
- Lead Sponsor
- Adaptive Phage Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Identify ideal bacteriophage treatment regimens based on improvements in disease control rates baseline Microbiological eradication of target pathogen identified at baseline
- Secondary Outcome Measures
Name Time Method Assess the tolerability of bacteriophage therapy At least 56 days Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events
Assess the safety of bacteriophage therapy At least 56 days Safety will be measured by the number and percent of treatment related adverse events.
Trial Locations
- Locations (8)
Universal Axon Clinical Research
🇺🇸Doral, Florida, United States
AMPM Research Clinic
🇺🇸Miami Gardens, Florida, United States
AdMed Research
🇺🇸Miami, Florida, United States
Innovation Medical Research Center, Inc
🇺🇸Palmetto Bay, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
James J. Peters VA Medical Center
🇺🇸Bronx, New York, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
DHR Health Institute for Research and Development
🇺🇸Edinburg, Texas, United States
Universal Axon Clinical Research🇺🇸Doral, Florida, United States