LBP-EC01 for Urinary Tract Infection
(ELIMINATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to stop taking continuous low dose antimicrobial prophylaxis and not use any medication for treating the current UTI for the first 10 days of the study. However, postmenopausal women can continue vaginal estrogen therapy if it has been stable for over 3 months.
Is LBP-EC01 (also known as TMP-SMX, Septra, Bactrim) generally safe for humans?
TMP-SMX is generally well tolerated, but it can cause some side effects like skin rashes, changes in kidney and liver function, and rare cases of mental confusion or hallucinations. Serious side effects are uncommon, but mild reactions like skin rashes and temporary changes in kidney or liver function have been reported.12345
How is the drug LBP-EC01 for urinary tract infections different from other treatments?
LBP-EC01 is unique because it combines trimethoprim-sulfamethoxazole (TMP-SMX), a common antibiotic for UTIs, with another component, potentially offering a novel approach to treatment. However, resistance to TMP-SMX is a concern, and its effectiveness may vary depending on local resistance patterns.46789
What data supports the effectiveness of the drug LBP-EC01, which includes trimethoprim-sulfamethoxazole, for treating urinary tract infections?
Who Is on the Research Team?
Paul Kim
Principal Investigator
Locus Biosciences
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Regimen Selection
An open-label, 30 patient, 3-arm PK assessment to evaluate optimal dosing regimen
Efficacy, Safety, Tolerability and Pharmacokinetics
A blinded, 288 patient, 1:1 randomized evaluation of the selected dose regimen versus placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LBP-EC01
- TMP/SMX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Locus Biosciences
Lead Sponsor
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland