What side effects are associated with this type of intervention?

Common treatments for urinary tract infections (UTIs) caused by E. coli include antibiotics such as quinolones, trimethoprim/sulfamethoxazole, nitrofurantoin, and cephalosporins. Quinolones can cause side effects like gastrointestinal upset, dizziness, and, rarely, tendonitis or tendon rupture. Trimethoprim/sulfamethoxazole may lead to rash, gastrointestinal disturbances, and, in rare cases, blood disorders. Nitrofurantoin is generally well-tolerated but can cause nausea, headache, and, rarely, pulmonary reactions. Cephalosporins can cause allergic reactions, gastrointestinal upset, and, in rare cases, biliary sludge. Bacteriophage therapy, such as the LBP-EC01 cocktail, is generally considered safe with fewer side effects, but potential reactions can include mild gastrointestinal symptoms and, rarely, immune responses.

What prior FDA approvals exist?

The FDA has approved various antibiotics for the treatment of urinary tract infections (UTIs), including beta-lactam antibiotics like amoxicillin and cephalosporins, as well as fluoroquinolones and nitrofurantoin. These treatments target a broad spectrum of bacterial pathogens, including E. coli, which is a common cause of UTIs. While traditional antibiotics remain the mainstay of UTI treatment, innovative approaches such as the recombinant bacteriophage cocktail LBP-EC01, which specifically targets and lyses multi-drug resistant E. coli, are currently being studied in clinical trials. This represents a novel therapeutic strategy that could complement or provide an alternative to conventional antibiotic therapies.

What other types of research exist?

Promising novel alternatives to LBP-EC01 for UTI treatment in 2024 may include: 1) Phage therapy using different bacteriophage cocktails targeting E. coli, 2) CRISPR-Cas systems designed to target and disrupt bacterial DNA, 3) Antimicrobial peptides that can kill multi-drug resistant bacteria, and 4) New classes of antibiotics or antibiotic adjuvants that enhance the efficacy of existing antibiotics against resistant strains.

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Virus Therapy

LBP-EC01 for Urinary Tract Infection (ELIMINATE Trial)

Phase 2

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"

Must not have

Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities, poorly-controlled diabetes mellitus, immunocompromising condition and/or treatment, or advanced renal disfunction.

Suspected or confirmed acute coronavirus disease 2019 (COVID-19) or recent COVID-19 infection with ongoing symptoms.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within the 6-month follow-up period

Summary

This trial is testing LBP-EC01, a virus mixture that targets E. coli bacteria, in patients with recurring UTIs caused by E. coli. The study aims to find the best dose and compare its effectiveness and safety with standard antibiotic treatment.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition affecting my bladder, diabetes, a weak immune system, or severe kidney issues.

Select...

I currently have or recently had COVID-19 with ongoing symptoms.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 and microbiologic response of uUTI caused by drug resistant E. coli as defined at Day 10 test of cure (TOC).

Secondary study objectives

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 CCMR of uUTI caused by E. coli at Day 10/TOC.

+3 more

Side effects data

From 2020 Phase 1 trial • 36 Patients • NCT04191148

21%

Headache

21%

Urinary tract infections

13%

Back pain

Vomiting

Dizziness

Pollakiuria

Dysuria

Hematuria

Rhinorrhea

Pneumonitis

Arthralgia

Spleen palpable

100%

80%

60%

40%

20%

Study treatment Arm

LBP-EC01

Placebo

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. IU LBP-EC01 on D1 and D2 with IV LBP-EC01 (1x10\^11 PFU) and oral TMP/SMX on D1 through D3.

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. IU placebo on D1 and D2 with IV placebo and oral TMP/SMX on D1 through D3.

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for urinary tract infections (UTIs) include antibiotics such as trimethoprim-sulfamethoxazole, nitrofurantoin, and fluoroquinolones. These antibiotics work by inhibiting bacterial DNA synthesis, protein synthesis, or cell wall formation, effectively killing or stopping the growth of the bacteria causing the infection. The LBP-EC01 trial explores a novel approach using a recombinant bacteriophage cocktail that specifically targets and lyses multi-drug resistant E. coli. This method is significant for UTI patients as it offers a potential solution to antibiotic resistance, providing an alternative treatment that can effectively eliminate the pathogenic bacteria without contributing to the growing issue of antibiotic resistance.