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LBP-EC01 for Drug-Resistant Urinary Tract Infections

This study, called the ELIMINATE Trial, is testing a new treatment called LBP-EC01 for acute uncomplicated urinary tract infections (UTIs) caused by E. coli bacteria that are resistant to common antibiotics. Researchers want to see if LBP-EC01 can help resolve your symptoms and clear the infection. You may be eligible if you are a woman between 18 and 75 years old with a history of UTIs, including one caused by antibiotic-resistant E. coli. The study will compare different doses of LBP-EC01, given both into the urethra (the tube that carries urine out of the body) and through an IV, against a placebo (an inactive substance) plus standard antibiotics. Success will be measured by how many patients have their symptoms go away and the infection cleared by Day 10.

Study design
This is a Phase 2 study with an initial open-label part involving 30 patients to find the best dose of LBP-EC01. The main part of the study will then involve 288 patients, randomly assigned to receive either LBP-EC01 plus antibiotics or a placebo plus antibiotics.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for symptom resolution and infection clearance around Day 10 after treatment. They will also measure levels of LBP-EC01 in your urine and blood for up to 48 hours after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05488340

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Locus Biosciences
~318 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:LBP-EC01 0.1 x IV doseLBP-EC01 0.01x IV DoseLBP-EC01 IV Infusion DosePlaceboLBP-EC01TMP/SMX

At a glance

Recruiting sites
12 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Day 1 to Day 5
+1 more outcome measured

Conditions

Urinary Tract Infections

Explore related trials

Urinary Tract Infection

Where it's being run

17 sites across 5 states
California7
Florida6
North Carolina2
Massachusetts1
Missouri1

Study leadership

  • Paul Kim · STUDY_DIRECTOR · Locus Biosciences

Who to contact

Locus Clinical Operations
[email protected]
(919) 495-4510
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli (as single pathogen or part of polymicrobial infection where E. coli is the predominant pathogen). Please note that the current infection can be used to meet the requirement of AMR E. coli documentation.
Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
Active acute uUTI infection defined by:
Willing to comply with all aspects of study design including study restrictions, blood, urine, and stool sampling, and scheduled study visits.
All sexually active female patients of childbearing potential must use highly effective contraception during the study and until 2 weeks after the last dose of study drug treatment.
Agrees to STOP continuous low dose antimicrobial prophylaxis and/or will maintain the same practices for post-coital antimicrobial prophylaxis to prevent UTI, as during the prior 12-months, for the entire study duration (throughout the 6-month follow-up period or study discharge).
Agrees to not use any prescription or non-prescription medication for the microbiological or symptomatic treatment of the presenting acute uUTI for the first 10 days of the study.
Capable of providing their own signed informed consent form (ICF) prior to any study-related procedures being performed.
If participating in Part 1 of the study, agrees to fast for ≥2 h prior to first dose of study drug on Day 1/Visit 1 except for drinking 240 mL of water with study drug administration.

Exclusion

Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/ Celsius, shaking chills, or other clinical manifestations suggestive of complicated UTI.
Treatment with other antibacterial drugs including those that are effective for treatment of the acute uUTI or prevention of recurrent UTI in the 5 days prior to Screening unless the recovered pathogen demonstrates resistance to the initial antibiotic and clinical symptoms persist. In postmenopausal women vaginal estrogen replacement therapy is permitted so long as patient meets all other eligibility criteria, that the dose and regimen has be stable for \> 3 months from Screening (D1/V1), and that there is no planned change to therapy through the 6-month follow-up period or study discontinuation.
Clinical symptoms for more than 5 days before Screening.
Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities that increase UTI risk or lead to a post void residual (PVR) urine volume \> 150mL, poorly controlled diabetes mellitus (diagnosed but is not being treated/managed by a physician's care or HbA1c \>8), current symptomatic or larger than 5mm renal calculi, or advanced renal dysfunction (determined by eGFR \< 45 mL/min/1.73 m2). Patients with vaginal prolapse beyond the hymen with Valsalva (e.g., when coughing).
Individuals considered to be immunocompromised.
Clinically significant serious unstable physical illness that in the investigator's opinion prevents patient from completing the study or prevents interpretation or resolution of clinical symptoms.
Pregnant or nursing women.
Exposure to any investigational drugs or other phage therapy 30 days prior to Screening (D1/V1) or prior to participation in this study. Patients who participate in Part 1 are not eligible for participation in Part 2.
Allergies to excipients of the study drug or antibiotics.
History of autonomic dysreflexia.
History of intravenous (IV) drug abuse or is currently using or has positive results for drugs of abuse at screening.
Patients who reside in a long-term care facility.
Suspected or confirmed acute coronavirus disease 2019 (COVID-19) or recent COVID-19 infection with ongoing symptoms.

What this trial 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 doseDay 1 to Day 5

    The regimen for LBP-EC01 when used concomitantly with TMP/SMX which optimizes pharmacokinetics (PK) for LBP-EC01 will be selected.

  • 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).Day 10

    The efficacy of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on resolution of acute uUTI clinical symptoms and demonstration of microbiologic response (CCMR) of acute uUTI caused by drug resistant E. coli will be assessed.