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New treatment option for Bacteriuria
Official title Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
ClinicalTrials.gov ID: NCT06559618
What this study is testing
What is Phage Therapy?
Phage Therapy is an investigational medicine, given as a twice-daily, being studied as a potential treatment for bacteriuria.
Also referred to as Phage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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) with a diagnosis of Spinal Cord Injury/Disease (SCI/D) and neurogenic bladder. Eligible participants may include inpatients in the...
- ASB with E. coli present in a quantity of ≥ 104 CFU/mL.
- Require an indwelling (transurethral or suprapubic) or intermittent catheterization for bladder drainage.
You likely can't join if
- Unable to provide informed consent for themselves.
- Received a new antibiotic expected to kill the Gram-negative organisms in the urine between initial enrollment urine culture and the time of...
- History of neutropenia, defined by ANC \< 1000 per µL within 6 months prior to screening.
- History of organ transplantation.
- Presence of a surgically modified bladder, except for a repaired ruptured bladder.
- HIV with a CD4 count \< 200 cells per µL.
See the full eligibility criteria
- 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) with a diagnosis of Spinal Cord Injury/Disease (SCI/D) and neurogenic bladder. Eligible participants may include inpatients in the SCI care unit or outpatients receiving care at participating sites...
- 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 attend clinic visits either (a) daily for the 7 days of treatment, or (b) on Day 1 and Day 7 of dosing. On Day 1, the participant...
- Unable to provide informed consent for themselves.
- Received a new antibiotic expected to kill the Gram-negative organisms in the urine between initial enrollment urine culture and the time of randomization.
- History of neutropenia, defined by ANC \< 1000 per µL within 6 months prior to screening.
- History of organ transplantation.
- Presence of a surgically modified bladder, except for a repaired ruptured bladder.
- HIV with a CD4 count \< 200 cells per µL.
- Unstable vital signs (e.g., fever, hypotension)
- 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...
- Known urinary obstruction.
- Medical devices in the urinary tract (other than urinary catheters)
- Unless deemed acceptable by the sponsor-investigator, prescription drugs, OTC medications and supplements that acidify the urine are excluded.
- Stage 4 or greater chronic kidney disease
- Pregnant or breastfeeding female
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.