Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
This study tests a new phage therapy treatment designed to safely reduce bacteria in the urine of people with spinal cord injuries who have neurogenic bladders. Researchers will monitor how well the treatment works and check for any side effects in this early-stage clinical trial.
Key Objective:The trial evaluates whether bacteriophage therapy can safely treat bacterial colonization in the bladder without causing harm to spinal cord injury patients.
Who to Consider:Adults with spinal cord injuries who have neurogenic bladders and persistent bacteria in their urine may be good candidates for this study.
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Adult (\> age 18) inpatients in the SCI care units with neurogenic bladders or outpatients in the SCI care clinics. 4. ASB with E. coli present in a quantity of ≥ 104 CFU/mL). 5. Require an indwelling (transurethral or suprapubic) or intermittent catheterization for bladder drainage. 6. 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 afterwards. 7. Participant will be hospitalized during the 7 days of treatment or will be willing to come into clinic to receive the first dose of IP and training (of participant and/or caregiver) on how to instill the IP into the bladder. Exclusion Criteria: 1. Unable to provide informed consent for themselves. 2. Received a new antibiotic expected to kill