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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~within the 6-month follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the 6-month follow-up period for reporting.

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 more

Side effects data

From 2020 Phase 1 trial • 36 Patients • NCT04191148
21%
Headache
21%
Urinary tract infections
13%
Back pain
8%
Hematuria
8%
Vomiting
8%
Dysuria
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
304 Previous Clinical Trials
100,608 Total Patients Enrolled
Paul KimStudy DirectorLocus Biosciences

Media Library

LBP-EC01 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05488340 — Phase 2 & 3
Urinary Tract Infection Research Study Groups: Part 1- Arm 4 (previously 1), Part 1- Arm 5 (previously 2), Part 1- Arm 6 (previously 3), Part 2: LBP-EC01, Part 2: Placebo
Urinary Tract Infection Clinical Trial 2023: LBP-EC01 Highlights & Side Effects. Trial Name: NCT05488340 — Phase 2 & 3
LBP-EC01 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488340 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prerequisites for participating in this experiment?

"This study is looking for 580 individuals that have a history of urinary tract infection. Patients must be aged 18 to 65 and meet the following criteria: -Have had 2 UTIs in the past 6 months or 3 UTIs in the past 12 months, with at least one being caused by E. coli -Evidence of pyuria (10 WBC/mL or more in a spun urine sample, 3 WBC/high power field or higher in an unspun urine sample, dipstick test positive for leukocytes, or positive catalase test) -At least 2 signs or symptoms of a UT"

Answered by AI

Are there any vacancies in this trial for new participants?

"The study you're interested in is still recruiting patients, as of 8/19/2022. It was originally posted on clinicaltrials.gov on 7/13/2022."

Answered by AI

What are the impacts that researchers hope to see from this clinical trial?

"The objective of this trial, which will be measured over a period of 7 days, is to assess the efficacy of LBP-EC01 in resolving clinical symptoms and demonstrating microbiologic response in patients with uncomplicated urinary tract infections caused by multidrug resistant E. coli. In addition to the primary outcome, this trial will also measure secondary outcomes including resolution of clinical symptoms and microbiologic response in patients with uncomplicated urinary tract infections caused by E. coli, immunogenicity, and safety and tolerability."

Answered by AI

How many individuals can join this clinical trial at its largest?

"From what is published on clinicaltrials.gov, it seems that this particular trial is recruiting patients at the moment. This specific trial was posted on 7/13/2022 and was updated as recently as 8/19/2022. The goal is to have 580 people participate from 14 different sites."

Answered by AI

Can adults participate in this program?

"The age requirements to participate in this study are that you must be over 18 and under 65."

Answered by AI

At how many hospitals is this research being conducted?

"There are 14 active sites for this study, all of which participating patients must visit. The locations include Miami, Anniston, Irvine and 11 other cities. To minimize the burden on participants, it is advised to select the clinical trial site nearest you."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
How old are they?
18 - 65
What site did they apply to?
Site 105
Site 102
Research Site 106
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Research Site 106: < 24 hours
  2. Site 105: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Multi-drug Resistant E. Coli (ELIMINATE Trial)
2022. "A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Multi-drug Resistant E. Coli (ELIMINATE Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05488340.
All > Uti
~222 spots leftby Jun 2025
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