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RECRUITING
NCT06559618
PHASE1

Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

Sponsor: Barbara Wells Trautner

View on ClinicalTrials.gov

Summary

This is a Phase 1b study to assess the safety, tolerability, PK, and PD of investigational phage therapy (IP) in adults with SCI and bladder colonization (ASB). It is a single-center, randomized, double-blind, placebo-controlled study in adults with SCI with neurogenic bladders and bacteriuria who use indwelling catheters, or who require intermittent catheterization for bladder drainage.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-02-03

Completion Date

2026-12

Last Updated

2025-05-14

Healthy Volunteers

No

Interventions

DRUG

Phage Therapy

A 20 mL sterile solution containing one to three individual phage drug substances (TPC) with total strength (potency) 3 x 10\^8 plaque-forming units (PFU), will be administered intravesicularly twice a day (one instillation in the morning and one in the evening \[at least six hours apart\], respectively) for 7 days. The selection of individual phages to include in the TPC are personalized/customized for each participant per phage susceptibility testing to the participant's urinary E. coli (testing is conducted by TAILФR Service Center). Each dose of TPC will be followed with a 10 mL flush of sterile 0.9% saline solution.

OTHER

Placebo

Sterile 0.9% saline solution also 20 mL, followed with a 10 mL flush of the same solution.

Locations (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, United States