Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04191148
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2019-12-04
Brief Title:
Safety Tolerability and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E Coli
Sponsor:
Locus Biosciences
Organization:
Locus Biosciences
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E Coli
Status:
COMPLETED
Status Verified Date:
2021-11
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:
Study LBx-1001 is a multi-center randomized double-blind study to assess the safety tolerability pharmacokinetics PK and pharmacodynamics PD of LBP-EC01 in patients with indwelling urinary catheters or requiring intermittent catheterization andor patients with asymptomatic bacteriuria caused by Escherichia coli E coli This study population has been selected because LBP-EC01 is a phage cocktail where active bacterial host engagement is required to allow for amplification of the phage and evaluation of the safety and PK of the phage cocktail Eligible patients will require confirmation of colonization with a urine sample taken within 10 days of randomization that cultures contain 103 E coli colony forming unit CFUmL without the patient having clinical signs or symptoms of an active urinary tract infection UTI requiring antibiotic treatment Patients should have E coli as the primary colonizing bacteria and must not have a secondary bacterial colonization at levels equal to or greater than that seen from E coli
Detailed Description:
Approximately 30 patients 18 years of age or older with a history of urinary tract infection or colonization caused by E coli who have indwelling urinary catheters or who require intermittent catheterization andor patients with asymptomatic bacteriuria caused by E coli colonization 103 CFUmL on microbiological diagnosis without clinical signs or symptoms of infection requiring antibiotic treatment will be enrolled Patients will be screened for presence of E coli colonization 103 CFUmL prior to randomization and evaluated for potential bacterial susceptibility to LBP-EC01
Secondary Objective To evaluate the pharmacodynamics PD of LBP-EC01 Exploratory Objective To explore the influence of LBP-EC01 on the urinary tract microbiota
Secondary Objective To evaluate the pharmacodynamics PD of LBP-EC01 Exploratory Objective To explore the influence of LBP-EC01 on the urinary tract microbiota
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