Actively Recruiting
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
Led by Barbara Trautner · Updated on 2026-05-05
30
Participants Needed
2
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided.
- Willingness to follow all study procedures and available for entire study.
- Adult aged over 18 years with spinal cord injury/disease and neurogenic bladder.
- Asymptomatic bacteriuria with E. coli at or above 10,000 CFU/mL.
- Use of indwelling (transurethral or suprapubic) or intermittent catheterization for bladder drainage.
- Women of childbearing potential and men with female partners of childbearing potential must use two forms of effective contraception during the study and for two weeks after.
- Participants will be hospitalized during the 7 days of treatment or willing to attend clinic visits daily for 7 days or on Day 1 and Day 7 of dosing.
- Receive in-person training on bladder instillation of investigational product on Day 1.
You will not qualify if you...
- Unable to provide informed consent.
- Received a new antibiotic expected to kill Gram-negative urine organisms between initial urine culture and randomization.
- History of neutropenia (ANC < 1000 per µL) within 6 months before screening.
- History of organ transplantation.
- Surgically modified bladder except repaired ruptured bladder.
- HIV with CD4 count less than 200 cells per µL.
- Unstable vital signs such as fever or low blood pressure.
- Symptoms of active urinary tract infection unless explained by non-urinary cause.
- Known urinary obstruction.
- Medical devices in the urinary tract other than urinary catheters.
- Use of prescription drugs, OTC medications, or supplements that acidify urine unless approved by the sponsor-investigator.
- Stage 4 or higher chronic kidney disease.
- Pregnant or breastfeeding female.
- Three or more episodes of autonomic dysreflexia in prior 30 days.
- Medical or psychiatric illness that would interfere with participation, including active, severe, or uncontrolled systemic diseases.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Washington University in St Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Barbara W Trautner, MD, PhD
CONTACT
R
Rogelio Hernandez, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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