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NCT06559618 · ClinicalTrials.gov registry record · Phase 1

Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

A Phase 1 study of Spinal Cord Injuries and Bacteriuria, sponsored by Barbara Wells Trautner.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT06559618: Recruiting Phase 1 study of Spinal Cord Injuries and Bacteriuria, sponsored by Barbara Wells Trautner.

NCT06559618 is a Phase 1 study of Spinal Cord Injuries and Bacteriuria that is actively recruiting participants, run by Barbara Wells Trautner. The registered enrollment target is 30 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06559618, a Phase 1 study of Spinal Cord Injuries and Bacteriuria, is actively recruiting participants, sponsored by Barbara Wells Trautner.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Safety and tolerability analysis of Adverse Events. The urinary symptom questionnaires provided by MedStar Health, USQNB will be used as a daily study diary. Participant's charts for AEs while they are hospitalized, and during study visits on days 14, 21, and 35 if they have been discharged before Day 14. Blood samples will be collected for chemistry and hematology on days 1, 3, 7, 14, 21, and 35. Urine samples will be collected to detect and analyze markers of inflammation on Days 1, 2, 3, 5

Interventions

  • OTHER Placebo
  • DRUG Phage Therapy

Study Locations (1)

Texas

  • Michael E. DeBakey VA Medical Center - Houston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-02-03
Est. Completion 2026-12
Phase Phase 1
Barbara Wells Trautner

1 total trials

What NCT06559618 shows while recruiting

NCT06559618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (51% lower).

The record links to 4 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06559618 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06559618 about?

NCT06559618 is a clinical study titled "Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria". 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 u...

What is the current status of trial NCT06559618?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-02-03. Estimated completion is 2026-12.

What conditions does trial NCT06559618 study?

This clinical trial studies the following conditions: Spinal Cord Injuries, Bacteriuria, Asymptomatic Bacteriuria, Escherichia Coli.

What interventions are being tested in trial NCT06559618?

The interventions under investigation include: Placebo (OTHER), Phage Therapy (DRUG).

Who is sponsoring clinical trial NCT06559618?

This trial is sponsored by Barbara Wells Trautner, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06559618 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Spinal Cord Injuries

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06559618's enrollment target sits among peer trials

30 90th of 202 higher than 99 of 202 other Spinal Cord Injuries trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06559618, the US trial registry maintained by the National Library of Medicine. NCT06559618 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.