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Treatment of acute urinary tract infections caused by drug-resistant E. coli using a bacteriophage cocktail

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

Phase 2 Interventional Locus Biosciences · NCT05488340

This study is testing a new treatment using a special virus mix to see if it can help people with urinary tract infections caused by tough-to-treat E. coli bacteria.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment318 (estimated)
Ages18 Years to 75 Years
SexFemale
SponsorLocus Biosciences Industry-sponsored
Locations17 sites (Fresno, California and 16 other locations)
Trial IDNCT05488340 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial evaluates the efficacy of LBP-EC01, a recombinant bacteriophage cocktail, in treating acute uncomplicated urinary tract infections (UTIs) caused by drug-resistant E. coli. The study consists of two parts: an initial open-label pharmacokinetic assessment with 30 patients to determine the optimal dosing regimen, followed by a randomized, blinded evaluation involving 288 patients comparing LBP-EC01 combined with antibiotics to a placebo with antibiotics. Patients must have an active UTI and a history of prior infections caused by E. coli.

Who should consider this trial

Good fit: Ideal candidates are individuals with a history of urinary tract infections caused by drug-resistant E. coli and currently experiencing an acute uncomplicated UTI.

Not a fit: Patients with UTIs caused by pathogens other than E. coli or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel and effective option for patients suffering from drug-resistant urinary tract infections.

How similar studies have performed: While bacteriophage therapy is a novel approach, similar studies have shown promise in treating bacterial infections, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Fresno, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Tract InfectionsLBP-EC01Urinary tract infectionE. coliBacteriophagePhagecrPhageRecombinant bacteriophage
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.