Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 3, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
BacteriuriaSpinal Cord InjuriesAsymptomatic BacteriuriaEscherichia Coli
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.

Trial Locations (1)

77030

RECRUITING

Michael E. DeBakey VA Medical Center, Houston

All Listed Sponsors
lead

Barbara Wells Trautner

OTHER