Bacteriophage Therapy in Patients With Urinary Tract Infections

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

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

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.

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.