Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

Launched by BARBARA WELLS TRAUTNER · Aug 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment called bacteriophage therapy for adults with spinal cord injuries who have a specific type of bacteria in their urine, known as asymptomatic bacteriuria (ASB). The goal is to see if this treatment is safe and how well it works for these patients, particularly those who rely on catheters to help with bladder drainage. The trial is taking place at one location, and participants will be randomly assigned to receive either the treatment or a placebo (a harmless substance that looks like the treatment but has no effect).

To be eligible for this study, participants must be adults over 18 years old with a spinal cord injury and have a certain level of E. coli bacteria in their urine. They should also be currently using catheters for bladder care. Participants will need to stay in the hospital for seven days during treatment or come in for training on how to use the treatment. Women and men with female partners who can have children will need to use two forms of birth control during the study. It’s important to know that certain health conditions or recent medical treatments may exclude some individuals from participating. Overall, this study aims to find a better way to manage urinary infections in patients with spinal cord injuries.

Gender

ALL

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 the Gram-negative organisms in the urine between initial enrollment urine culture and the time of randomization.
• • 3. History of neutropenia, defined by ANC \< 1000 per µL within 6 months prior to screening.
• • 4. History of organ transplantation.
• • 5. Presence of a surgically-modified bladder, except for a repaired ruptured bladder.
• • 6. HIV with a CD4 count \< 200 cells per µL.
• • 7. Unstable vital signs (e.g., fever, hypotension)
• • 8. Symptoms of active urinary tract infection defined as fever, autonomic dysreflexia, generalized increase in spasticity, bladder spasms, new sweating, increase or change in lower abdominal pain, increase in burning or pain when passing urine, increase in burning or pain during catheterization, blood in the urine, or an increased sensation of urinary urgency (MedStar Health, Urinary Symptom Questionnaires for Neurogenic Bladder \[USQNB\]) (Section 11.2). The presence of any one of these symptoms, unless explained by a non-urinary or non-infectious condition, will be an exclusion criterion.
• • 9. Known urinary obstruction.
• • 10. Medical devices in the urinary tract (other than urinary catheters)
• • 11. Unless deemed acceptable by the sponsor-investigator, prescription drugs, OTC medications and supplements that acidify the urine are excluded.
• • 12. Stage 4 or greater chronic kidney disease
• • 13. Pregnant or breastfeeding female
• • 14. Three or more episodes of autonomic dysreflexia in prior 30 days; defined as those patients who have a SCI and who have had a documented sudden increase in systolic blood pressure of greater than 40 mmHg due to an irritation or stimulation (including bladder or bowel irritation) below the level of the SCI. Autonomic dysreflexia can include findings of hypertensive crisis or emergency, clinically significant bradycardia/tachycardia, severe headache or other severe reaction requiring an acute intervention. The sponsor-investigator will evaluate if a history of severe autonomic dysreflexia is suspected but not clearly identified.
• • 15. In the opinion of the sponsor-investigator, medical or psychiatric illness that would interfere with participation such as active, severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease.