Bacteriophage Therapy for Spinal Cord Injury Patients with Bacteriuria
This study is testing a treatment called Phage Therapy for adults aged 18 and older who have spinal cord injuries and a bladder infection (bacteriuria) caused by E. coli bacteria. Phage Therapy uses special viruses (phages) that can kill bacteria. The main goal is to see if Phage Therapy is safe and well-tolerated over two years. You would either receive Phage Therapy or a placebo (a sterile saline solution, which has no active medicine). The study plans to enroll about 30 participants, but its current recruitment status is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either Phage Therapy or a placebo without knowing which one they are getting. Approximately 30 adults with spinal cord injury and bacteriuria will participate.
- What's involved
- You would undergo a screening period of up to 30 days. If eligible, you would receive the study treatment (Phage Therapy or placebo) instilled into your bladder twice a day for 7 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would have follow-up assessments at Days 14, 21, 28, and 35. The study will evaluate safety and tolerability for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Barbara W Trautner, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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What this trial measures
- 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)2 years
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, 7, 14, 21, and 35.