Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
ID05488340

A Phase 2, Double-blind, Randomized, Active-controlled Evaluation of LBP-EC01 with Antibiotic in Treating Acute Uncomplicated Urinary Tract Infection Caused by Drug Resistant E. Coli

Led by Locus Biosciences · Updated on 2026-03-20

318

Participants Needed

17

Research Sites

26 weeks

Total Duration

On this page

Sponsors

L

Locus Biosciences

Lead Sponsor

P

Parexel

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for women with acute uncomplicated urinary tract infections (UTI) caused by drug-resistant E. coli. The study aims to find the best dosing regimen and compare the treatment's safety, tolerability, pharmacokinetics, and effectiveness against placebo when combined with an antibiotic, trimethoprim/sulfamethoxazole (TMP/SMX). Eligible participants must have an active acute UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts. Part 1 is an open-label dose regimen selection with 30 patients divided into three groups receiving different doses of LBP-EC01 via intraurethral and intravenous administration alongside oral TMP/SMX over three days. Part 2 is a double-blind, randomized comparison of the selected LBP-EC01 dose regimen versus placebo, both with oral TMP/SMX, in 288 patients. Treatment in Part 2 lasts three days, with doses given twice daily for TMP/SMX and specified LBP-EC01 doses on days 1 to 3. Participants will provide urine, blood, and stool samples for microbiological and pharmacokinetic analyses. Researchers will monitor clinical symptoms, microbiologic responses, adverse events, and immunogenicity over several follow-up visits up to six months. The main outcomes include drug levels in urine and blood, symptom resolution, and microbiological cure by day 10. Safety and tolerability are also closely observed throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 75 years
  • History of urinary tract infection in the past 12 months with prior or current uncomplicated UTI caused by antimicrobial-resistant E. coli
  • Able to provide a mid-stream, clean catch urine sample for microbiological analysis
  • Active acute uncomplicated urinary tract infection with evidence of pyuria and at least two UTI symptoms (dysuria, frequency, urgency, or suprapubic pain)
  • Willing to comply with study procedures, restrictions, and scheduled visits
  • Sexually active females of childbearing potential must use highly effective contraception during the study and for 2 weeks after last dose
  • Agree to stop low dose antimicrobial prophylaxis or maintain prior practices for preventing UTI during the study
  • Agree not to use other medications for treating the acute UTI for the first 10 days of the study
  • Capable of providing signed informed consent
  • If in Part 1, agree to fast for at least 2 hours before first dose except drinking water
Not Eligible

You will not qualify if you...

  • Signs or symptoms of systemic illness such as fever above 38°C, shaking chills, or complicated UTI
  • Use of other antibacterial drugs effective against acute UTI within 5 days before screening unless resistant pathogen persists
  • Clinical symptoms lasting more than 5 days before screening
  • Presence of urinary catheters, urinary tract abnormalities increasing UTI risk, or post-void residual urine volume over 150 mL
  • Poorly controlled diabetes or advanced kidney dysfunction
  • Current symptomatic or larger than 5mm kidney stones
  • Vaginal prolapse beyond the hymen
  • Immunocompromised individuals
  • Serious unstable physical illness preventing study completion
  • Pregnant or nursing women
  • Exposure to investigational drugs or phage therapy within 30 days before screening
  • Allergies to study drug or antibiotic components
  • History of autonomic dysreflexia
  • History or current intravenous drug abuse
  • Residents of long-term care facilities
  • Suspected or confirmed COVID-19 or recent infection with symptoms ongoing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 3 days

Participants receive a dose regimen selection involving intraurethral and intravenous doses of LBP-EC01 along with oral antibiotics to determine the optimal dosing.

Daily visits or dosing on Days 1 through 3

Treatment

Duration - 3 days

Participants receive the selected dose regimen of LBP-EC01 or placebo along with oral antibiotics for acute uncomplicated urinary tract infection caused by drug resistant E. coli.

Daily dosing on Days 1 through 3

Follow-up

Duration - Up to 6 months

Participants are monitored for resolution of symptoms, microbiologic response, and safety assessments after treatment completion.

Visits on Day 10, Day 21, and additional assessments within 6 months

Trial Site Locations

Total: 17 locations

1

Research Site 138

Fresno, California, United States, 93710

Completed

2

Research Site 131

Lancaster, California, United States, 93534

Actively Recruiting

3

Research Site 123

Los Angeles, California, United States, 90027

Actively Recruiting

4

Research Site 125

Montebello, California, United States, 90640

Completed

5

Research Site 152

Murrieta, California, United States, 92563

Actively Recruiting

6

Research Site 137

San Diego, California, United States, 92037

Actively Recruiting

7

Research Site 126

Tustin, California, United States, 92780

Actively Recruiting

8

Research Site 102

Doral, Florida, United States, 33166

Actively Recruiting

9

Research Site 151

Hialeah, Florida, United States, 33013

Actively Recruiting

10

Research Site 140

Jensen Beach, Florida, United States, 34957

Completed

11

Research Site 103

Miami, Florida, United States, 33176

Actively Recruiting

12

Research Site 149

Miami, Florida, United States, 33176

Actively Recruiting

13

Research Site 153

Ocala, Florida, United States, 34473

Actively Recruiting

14

Research Site 120

Boston, Massachusetts, United States, 02115

Completed

15

Research Site 154

St Louis, Missouri, United States, 63141

Actively Recruiting

16

Research Site 145

Raleigh, North Carolina, United States, 27708

Actively Recruiting

17

Research Site 118

Winston-Salem, North Carolina, United States, 27157

Completed

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Research Team

L

Locus Clinical Operations

P

Paul Kim

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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Published Research Related To This Trial

Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail, in uncomplicated urinary tract infections due to Escherichia coli (ELIMINATE): the randomised, open-label, first part of a two-part phase 2 trial.

Paul Kim, Ana M Sanchez, Taylor J R Penke...

https://pubmed.ncbi.nlm.nih.gov/39134085