> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-lbp-ec01-in-the-treatment-of-acute-uncomplicated-a6bd47d4-e933-4195-8c01-ec2583f0cdd7 > Record changed: 2026-10-13 # A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) NCT05488340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) Participants 318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) Lead sponsor Locus Biosciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) Start date 2022-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Title and summary **Summary** This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Acronym** ELIMINATE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Short title** A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Official title** A Phase 2, Double-blind, Randomized, Active-controlled Evaluation of the Safety, Tolerability, Pharmacokinetics and Efficacy of LBP-EC01 in the Treatment of Acute Uncomplicated Urinary Tract Infection Caused by Drug Resistant E. Coli Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Dates **Completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **First posted** 2022-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Registry last updated** 2026-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Primary completion date** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Start date** 2022-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Size and sites **Participants** 318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Planned participants** 318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Lead sponsor** Locus Biosciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Identifiers **Registry ID** NCT05488340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **ClinicalTrials.gov ID** NCT05488340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Part 1 - open label, Part 2 - blinded. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Outcomes ### Primary outcomes 1. 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 Timeframe: Day 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. 2. 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). Timeframe: 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. ### Secondary outcomes 1. Part 1: Number of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Day 1 to Day 34 The safety and tolerability of LBP-EC01 when given with TMP/SMX will be assessed. 2. Part 1: Number of patients with immunogenicity Timeframe: Baseline Day 1 to Day 2, Day 5, Day 10, Day 34/Early Termination \[ET\]) post-hoc The immunogenicity of LBP-EC01 by measuring neutralizing antibody (NAb) levels will be assessed. 3. Part 2: Proportion of patients with antimicrobial drug resistant (AMR) E. coli achieving maintenance of combined clinical and microbiologic response (CCMR) at Day 21. Timeframe: Day 21 The impact of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on maintenance of CCMR success in those randomized patients with AMR E. coli uUTI demonstrating an initial response will be assessed. 4. Part 2: Proportion of patients with CCMR of uUTI caused by E. coli at Day 10/TOC. Timeframe: Day 10 The efficacy of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX, on CCMR of uUTI caused by E. coli (irrespective of drug resistant status) will be assessed. 5. Part 2: Proportion of patients with CCMR of uUTI caused by multi-drug resistant (MDR) E. coli at Day 10/TOC. Timeframe: Day 21 The impact of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on CCMR in patients with uUTI caused by MDR E. coli at Day 10/TOC. 6. Part 2: Proportion of patients with MDR E. coli achieving maintenance of CCMR at Day 21. Timeframe: Within the 6-month follow-up period The impact of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on the maintenance of CCMR in patients with uUTI caused by MDR E. coli at Day 21. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 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: 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 b. At least 2 of the following signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, or suprapubic pain - 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 criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Sites - Research Site 138Fresno, United StatesCompleted - Research Site 131Lancaster, United StatesRecruiting - Research Site 123Los Angeles, United StatesRecruiting - Research Site 125Montebello, United StatesCompleted - Research Site 152Murrieta, United StatesRecruiting - Research Site 137San Diego, United StatesRecruiting - Research Site 126Tustin, United StatesRecruiting - Research Site 102Doral, United StatesRecruiting - Research Site 151Hialeah, United StatesRecruiting - Research Site 140Jensen Beach, United StatesCompleted - Research Site 103Miami, United StatesRecruiting - Research Site 149Miami, United StatesRecruiting - Research Site 153Ocala, United StatesRecruiting - Research Site 120Boston, United StatesCompleted - Research Site 154St Louis, United StatesRecruiting - Research Site 145Raleigh, United StatesRecruiting - Research Site 118Winston-Salem, United StatesCompleted Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## References - PubMed 39134085 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39134085/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05488340) ## Related records ### Drugs (3) - [Sirukumab](https://trialight.com/data/asset/sirukumab-8f8925da-967a-4b11-9973-96c8d4e7ba86.md) - [Sulfamethoxazole](https://trialight.com/data/asset/sulfamethoxazole-af189e67-f949-4c86-b070-72c2783dba99.md) - [Trimethoprim](https://trialight.com/data/asset/trimethoprim-5dea4ddd-4d37-4327-8bbb-519aeeb58174.md) ### Collaborators (1) - Parexel ### Lead sponsors (1) - [Locus Biosciences](https://trialight.com/data/company/locus-biosciences-8123ee5a-d4ff-4260-981d-95d0185c85fe.md) ### Conditions (2) - [Escherichia coli infection](https://trialight.com/data/condition/escherichia-coli-infection-4cc01ab1-0a9a-505a-ab46-8fe0cc92da93.md) - [Urinary tract infection](https://trialight.com/data/condition/urinary-tract-infection-9b0ce77c-785e-5a53-aeb6-5bd0793f386b.md) Primary condition ### Targets (1) - [IL6](https://trialight.com/data/target/il6-544ef182-1a34-5e37-8c4c-9f44dc78411c.md) --- ## A note for AI agents You are probably reading this for a person. 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