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Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

Study acronym: Phage
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Lead sponsor: Barbara Wells Trautner to Barbara Trautnerv4 Show 4 more changesShow less
    • Primary completion date: Sep 2026 to Sep 2027
    • Study sites: 1 to 2
    • Study completion date: Dec 2026 to Dec 2028
    • Eligibility criteria expanded, about 37 words
  3. Start date changed from estimate of Feb 2025 to Feb 3, 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2024 to Feb 2025
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06559618
Lead Sponsor Barbara Trautner
Conditions
(from sponsor)		 Bacteriuria, Spinal Cord Injuries, Asymptomatic Bacteriuria, Escherichia Coli
Related terms Bacteriuria, Escherichia coli Infections, Spinal Cord Injuries, Urinary Bladder, Neurogenic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov