RecruitingPhase 2NCT05488340

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

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


Sponsor

Locus Biosciences

Enrollment

318 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of treatment called bacteriophage therapy (LBP-EC01) for uncomplicated urinary tract infections (UTIs) caused by antibiotic-resistant E. coli bacteria. Bacteriophages are tiny viruses that specifically target and kill bacteria — they don't harm human cells. The goal is to see if this treatment can clear drug-resistant UTIs where standard antibiotics may not work. You may be eligible if: • You are a woman aged 18 to 75 • You have had a UTI in the past 12 months caused by antibiotic-resistant E. coli • You currently have an active UTI with symptoms such as painful urination, frequent urination, urgency, or pelvic pain • You can provide a urine sample for testing • You are willing to stop other UTI antibiotics for the first 10 days of the study You may NOT be eligible if: • You have signs of a complicated or severe infection (fever above 38°C, chills, or other systemic symptoms) • You are pregnant or breastfeeding • You have an indwelling urinary catheter or significant urinary tract abnormalities • You have poorly controlled diabetes (HbA1c above 8) or severely reduced kidney function • You are immunocompromised • You have had symptoms for more than 5 days before screening • You have used another antibiotic for this UTI in the last 5 days (unless resistant) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLBP-EC01 0.1 x IV dose

Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.6mL of LBP-EC01 (approximately 1x10\^11 PFU) diluted in 0.4mL of Lactated Ringer's solution given on Days 1 through Day 3.

DRUGLBP-EC01 0.01x IV Dose

Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.06 mL of LBP-EC01 (approximately 1x10\^10 PFU) diluted in 0.94 mL of Lactated Ringer's solution given on Days 1 through Day 3.

DRUGLBP-EC01 IV Infusion Dose

Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous infusion dose of 6mL of LBP-EC01 (approximately 1x10\^12 PFU) diluted in 94 mL of Lactated Ringer's solution given over 2 hours on Days 1 through Day 3.

DRUGPlacebo

Dose regimen selected from Part 1 of placebo (Tris buffer).

DRUGLBP-EC01

Dose regimen selected from Part 1 of LBP-EC01 (1x10\^10 - 1x10\^13 PFU) per dose.

DRUGTMP/SMX

TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.


Locations(17)

Research Site 138

Fresno, California, United States

Research Site 131

Lancaster, California, United States

Research Site 123

Los Angeles, California, United States

Research Site 125

Montebello, California, United States

Research Site 152

Murrieta, California, United States

Research Site 137

San Diego, California, United States

Research Site 126

Tustin, California, United States

Research Site 102

Doral, Florida, United States

Research Site 151

Hialeah, Florida, United States

Research Site 140

Jensen Beach, Florida, United States

Research Site 103

Miami, Florida, United States

Research Site 149

Miami, Florida, United States

Research Site 153

Ocala, Florida, United States

Research Site 120

Boston, Massachusetts, United States

Research Site 154

St Louis, Missouri, United States

Research Site 145

Raleigh, North Carolina, United States

Research Site 118

Winston-Salem, North Carolina, United States

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NCT05488340


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