Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559618
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1B Study to Assess Safety Tolerability Pharmacokinetics and Pharmacodynamics of Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Phage
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
Detailed Description:
Approximately 30 participants will be randomized 11 to receive either investigational phage therapy 3 x 108 PFU phages or inert placebo sterile normal saline solution will be administered intravesicularly instilled into the participants bladder via catheter twice a day BID for 7 days the investigational phage therapies are personalized for each participant per phage susceptibility testing to the predominant E coli pathogen in the participants bladder A mixture of up to three phages in a sterile solution will comprise the investigational phage therapy The study duration for participants will be up to 65 days which includes up to 30 days for screening 7 days of IP treatment and post-treatment assessments at Days 14 21 28 and 35 7 14 21 and 28 days after the End of Treatment EOT on Day 7 respectively Day 35 is defined as the EOS The investigators will strive to enroll participants who are receiving inpatient care in the Spinal Cord Injury units but enrollment of outpatients with SCI is also possible Study enrollment will continue for up to 30 evaluable participants
The study will consist of a Screening Period of up to 30 days On Day -1 eligible participants will be randomized to investigational phage therapy or placebo The Treatment Period Days 1-7 is 7 days and participants will receive a total of 14 doses of IP The EOT will be after IP dose 14 on Day 7 The Follow-up Period is 35 days starting the day after the EOT with study assessments on Days 14 21 and Day 35 EOS Adverse event data will be collected throughout the study from Treatment Day 1 through the EOS
The study will consist of a Screening Period of up to 30 days On Day -1 eligible participants will be randomized to investigational phage therapy or placebo The Treatment Period Days 1-7 is 7 days and participants will receive a total of 14 doses of IP The EOT will be after IP dose 14 on Day 7 The Follow-up Period is 35 days starting the day after the EOT with study assessments on Days 14 21 and Day 35 EOS Adverse event data will be collected throughout the study from Treatment Day 1 through the EOS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None