Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409819
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-23
Brief Title:
Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Phase 1 2 Trial of Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This proposal will take an important first step in the study of phage therapy for treatment of recurrent urinary tract infection rUTI in female kidney transplant recipients KTR a common condition that is associated with increasing multidrug resistance sickness loss of kidney function and death The investigators will conduct a randomized phase III pilot clinical trial of targeted phage therapy versus placebo in asymptomatic female KTR with a history of rUTI due to Escherichia coli and Klebsiella pneumoniae to assess safety tolerability and feasibility of this approach possible efficacy and changes in the gut and urinary microbiome during the 180 days of the study This highly innovative and impactful proposal will provide proof of concept data and also inform the design of a subsequent larger phase III clinical trial of phage therapy for rUTI treatment in KTR and will have broad downstream effects within the fields of infectious diseases and transplantation
Detailed Description:
The overarching hypothesis is that phage therapy directed against E coli and K pneumoniae in female KTR is safe and associated with a reduction in UTI event rate via a targeted impact on the gut and urinary microbiome This is a Phase 1 2 randomized placebo-controlled clinical trial
A description of methods to be used to minimize bias Participants will be randomized to one of 2 arms - one active intervention phage therapy and the second is active intervention control arm normal saline placebo Participants will not be aware of study assignment and the medication delivered to them will look identical - clear 1mL solution in a plastic needless syringe
The number of study groupsarms and study intervention duration
Investigators plan to enroll participants that fulfill eligibility criteria until they reach their goal of 16 participants in each arm total N 32
This clinical trial will evaluate the effect of phage only without concomitant antibiotics compared to placebo for UTI prevention in asymptomatic female KTR with a history of rUTI There are no rigorous published trials testing this approach nor are there new therapeutics for rUTI in KTR on-market at this time Most IND cases or trials compare phage plus antibiotic which limits the ability to isolate the contribution from phage to treatment success The proposed research will utilize a phase III pilot trial designed to assess the safety tolerability and feasibility of therapy compare potential efficacy and assess changes to microbiome profiles in the female participants who will receive either phage or placebo As the participants will be treated when they are asymptomatic no active control is needed and so Investigators will use normal saline placebo
A description of methods to be used to minimize bias Participants will be randomized to one of 2 arms - one active intervention phage therapy and the second is active intervention control arm normal saline placebo Participants will not be aware of study assignment and the medication delivered to them will look identical - clear 1mL solution in a plastic needless syringe
The number of study groupsarms and study intervention duration
Investigators plan to enroll participants that fulfill eligibility criteria until they reach their goal of 16 participants in each arm total N 32
This clinical trial will evaluate the effect of phage only without concomitant antibiotics compared to placebo for UTI prevention in asymptomatic female KTR with a history of rUTI There are no rigorous published trials testing this approach nor are there new therapeutics for rUTI in KTR on-market at this time Most IND cases or trials compare phage plus antibiotic which limits the ability to isolate the contribution from phage to treatment success The proposed research will utilize a phase III pilot trial designed to assess the safety tolerability and feasibility of therapy compare potential efficacy and assess changes to microbiome profiles in the female participants who will receive either phage or placebo As the participants will be treated when they are asymptomatic no active control is needed and so Investigators will use normal saline placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None