A Phase 1B Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 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 use indwelling catheters, or who require intermittent catheterization for bladder drainage.
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Adult (\> age 18) inpatients in the SCI care units with neurogenic bladders or outpatients in the SCI care clinics.
• ASB with E. coli present in a quantity of ≥ 104 CFU/mL).
• Require an 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 afterwards.
• 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.