RECRUITING

Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

Conditions

Bacteriuria Spinal Cord Injuries Asymptomatic Bacteriuria Escherichia Coli Bacteriophage Phage Therapy Spinal Cord Injury Intravesicular infusion Neurogenic Bladder Intermittent catheterization Randomized clinical trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1B Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

Quick Facts

Study Start:2025-02

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06559618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Barbara W Trautner, MD, PhD

CONTACT

713 440 4438

trautner@bcm.edu

Rogelio Hernandez, MS

CONTACT

rogeliog@bcm.edu

Principal Investigator

Barbara W Trautner, MD, PhD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Barbara Wells Trautner

Barbara W Trautner, MD, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Bacteriophage
Bacteriuria
Phage Therapy
Spinal Cord Injury
Intravesicular infusion
Neurogenic Bladder
Intermittent catheterization
Randomized clinical trial

Additional Relevant MeSH Terms

Bacteriuria
Spinal Cord Injuries
Asymptomatic Bacteriuria
Escherichia Coli