A Phase 1B Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

What this Trial Is About

Researchers are evaluating an investigational phage therapy for adults with spinal cord injury (SCI) who have neurogenic bladders colonized by Escherichia coli bacteria. This Phase 1b study aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the therapy. Participants have bacteriuria and use either indwelling catheters or require intermittent catheterization for bladder drainage. The study is randomized, double-blind, placebo-controlled, and conducted at a single center. About 30 participants will be randomized to receive either the investigational phage therapy or a placebo. The phage therapy involves a personalized mixture of up to three phages targeting the participant's dominant E. coli strain. This sterile solution is instilled directly into the bladder via catheter twice daily for 7 days. The placebo group receives sterile saline solution administered the same way and schedule. Treatment includes 14 doses over 7 days, followed by a flush of sterile saline after each dose. Participants may be inpatients or outpatients and will undergo up to 30 days of screening before randomization. After treatment, follow-up visits occur on Days 14, 21, 28, and 35 to monitor safety and collect data. Assessments include adverse event monitoring, pharmacokinetic and pharmacodynamic evaluations, and bladder-related health checks. The total study duration per participant is up to 65 days. Safety and tolerability are the primary outcomes measured during and after treatment.

Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria