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Virus Therapy
LBP-EC01 for Urinary Tract Infection (ELIMINATE Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Locus Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of recurrent UTI defined as ≥2 UTIs in the past 6 months or ≥ 3 UTIs in the past 12 months prior to Screening (Day 1/Visit 1) with at least one of these caused by E. coli (as single pathogen or part of polymicrobial infection where E. coli was the predominant pathogen at quantitation ≥ 1.0 × 10^5 colony forming units [CFU]/mL) based on culture results/documentation.
a. Evidence of pyuria: i. >10 white blood cell (WBC)/mL3 on microscopic evaluation of spun, clean, mid-stream urine specimen or >3 WBC/high power field on unspun clean, mid-stream urine specimen, AND/OR ii. Dipstick analysis of a clean, mid-stream urine specimen positive for leukocytes, AND/OR iii. Positive catalase test of a clean, mid-stream urine specimen. AND b. At least 2 of the following signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, or suprapubic pain"
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the 6-month follow-up period
Awards & highlights
ELIMINATE Trial Summary
This trial is testing a new drug to see if it's better than placebo at treating urinary tract infections caused by E. coli.
Who is the study for?
This trial is for people who've had at least 2 UTIs in the past 6 months or 3 in the last year, with one caused by E. coli. They must have current symptoms of a UTI and not be using certain products like cranberry or probiotics. Sexually active women must use contraception, and participants can't take other UTI medications for the first 10 days.Check my eligibility
What is being tested?
The ELIMINATE Trial is testing LBP-EC01, a bacteriophage cocktail against drug-resistant E. coli causing UTIs. It's compared to placebo alongside antibiotics in patients with recurrent infections to find an optimal dose and assess effectiveness.See study design
What are the potential side effects?
Specific side effects are not listed but may include typical reactions to IV infusions such as irritation at the injection site, allergic reactions, or general discomfort.
ELIMINATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had 2 or more UTIs in the last 6 months, or 3 or more in the last year, with at least one caused by E. coli.
Select...
I have signs of a UTI and my urine tests show infection.
Select...
I agree to stop using certain products and treatments for UTI prevention during the study.
Select...
I have had 2 or more UTIs in the last 6 months, or 3 or more in the last year, with at least one caused by E. coli.
Select...
I have a UTI with pain, frequent or urgent urination, and my tests show infection.
Select...
I can sign the consent form for the study myself.
ELIMINATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the 6-month follow-up period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the 6-month follow-up period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Levels of LBP-EC01 in urine and blood measured by quantitative plaquing assay across the treatment period and over 48 h after the last dose
Part 2: Proportion of patients with resolution of clinical symptoms of a uncomplicated urinary tract infection (uUTI) and microbiologic response of uUTI caused by multidrug resistant or multidrug resistance (MDR) E. coli as defined at Day 10
Secondary outcome measures
Part 1: Number of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part 1: Number of patients with immunogenicity
Part 2: Proportion of patients with E. coli achieving maintenance of clinical and microbiologic response at Day 21
+3 moreSide effects data
From 2020 Phase 1 trial • 36 Patients • NCT0419114821%
Headache
21%
Urinary tract infections
13%
Back pain
8%
Hematuria
8%
Dysuria
8%
Vomiting
8%
Dizziness
8%
Pollakiuria
8%
Rhinorrhea
4%
Arthralgia
4%
Spleen palpable
4%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
LBP-EC01
Placebo
ELIMINATE Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: LBP-EC01Experimental Treatment2 Interventions
LBP-EC01 given by dose regimen selected from Part 1 and oral TMP/SMX.
Group II: Part 1- Arm 6 (previously 3)Experimental Treatment2 Interventions
Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 infusion (1x10^12 PFU) and oral TMP/SMX on D1 through D3.
Group III: Part 1- Arm 5 (previously 2)Experimental Treatment2 Interventions
Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10^10 PFU) and oral TMP/SMX on D1 through D3.
Group IV: Part 1- Arm 4 (previously 1)Experimental Treatment2 Interventions
Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10^11 PFU) and oral TMP/SMX on D1 through D3.
Group V: Part 2: PlaceboPlacebo Group2 Interventions
Placebo given by dose regimen selected from Part 1 and oral TMP/SMX.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TMP/SMX
2009
N/A
~300
LBP-EC01
2019
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Locus BiosciencesLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
ParexelIndustry Sponsor
305 Previous Clinical Trials
100,534 Total Patients Enrolled
Paul KimStudy DirectorLocus Biosciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a UTI with pain, frequent or urgent urination, and my tests show infection.I am using effective birth control and will continue for 2 weeks after my last treatment.I have had symptoms for more than a week.I haven't taken antibiotics for UTI in the last 3 days, unless they didn't work and my symptoms continued.I have had a fever over 38°C, shaking chills, or signs of a severe UTI.I have signs of a UTI and my urine tests show infection.You are allergic to inactive ingredients in the study drug or antibiotics.You have a history of a condition called autonomic dysreflexia.You have a history of using drugs through a needle or are currently using drugs that are not allowed in the study.I've had 2 or more UTIs in the last 6 months, or 3 or more in the last year, with at least one caused by E. coli.I agree to stop using certain products and treatments for UTI prevention during the study.I can provide a urine sample for testing.I agree to stop using certain products and treatments to prevent UTIs for the study duration.I can sign the consent form for the study myself.I agree not to take any medication for my UTI for the first 10 days of the study.I currently have or recently had COVID-19 with ongoing symptoms.I have had 2 or more UTIs in the last 6 months, or 3 or more in the last year, with at least one caused by E. coli.I am using effective birth control and will continue for 2 weeks after my last treatment.I agree not to take any medication for my UTI for the first 10 days of the study.I have a condition affecting my bladder, diabetes, a weak immune system, or severe kidney issues.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1- Arm 4 (previously 1)
- Group 2: Part 1- Arm 5 (previously 2)
- Group 3: Part 1- Arm 6 (previously 3)
- Group 4: Part 2: LBP-EC01
- Group 5: Part 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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