Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Barbara Trautner
Study ID
NCT06559618
Phase
PHASE1
Status
Recruiting
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Conditions

  • Asymptomatic Bacteriuria
  • Bacteriuria
  • Escherichia Coli
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phage Therapy — DRUG
    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.
  • Placebo — OTHER
    Sterile 0.9% saline solution also 20 mL, followed with a 10 mL flush of the same solution.

Study Details

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.

Key Dates

Start date
Feb 3, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phage Arm
    A sterile solution of one to three individual phages (cocktail) (3 x 10\^8 plaque forming units \[PFU\]) phage(s) will be administered intravesicularly (instilled into the participant's bladder via catheter) twice a day for 7 days. The name of the active treatment IP is TAILФR Phage Cocktail (TPC).
  • Placebo Comparator: Placebo Arm
    Sterile 0.9% saline solution will be instilled into the bladder via catheter twice a day for 7 days

Primary Outcome Measure

To evaluate the safety and tolerability of phage therapy in adults ≥18 years of age with spinal cord injury (SCI) and bacteriuria with Escherichia coli (E. coli) [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Washington University in St LouisSt LouisMissouri63110
Barbara W Trautner, MD, PhD
[email protected]
Michael E. DeBakey VA Medical CenterHoustonTexas77030
Eva Amenta, MD
[email protected]

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By research site
Washington University in St Louis· St Louis, MOMichael E. DeBakey VA Medical Center· Houston, TX

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