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

Part of paid clinical trials in Fresno, California.

Sponsor
Locus Biosciences
Study ID
NCT05488340
Phase
PHASE2
Status
Recruiting
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Conditions

  • Urinary Tract Infections

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LBP-EC01 0.1 x IV dose — DRUG
    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.
  • LBP-EC01 0.01x IV Dose — DRUG
    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.
  • LBP-EC01 IV Infusion Dose — DRUG
    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.
  • Placebo — DRUG
    Dose regimen selected from Part 1 of placebo (Tris buffer).
  • LBP-EC01 — DRUG
    Dose regimen selected from Part 1 of LBP-EC01 (1x10\^10 - 1x10\^13 PFU) per dose.
  • TMP/SMX — DRUG
    TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.

Study Details

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.

Key Dates

Start date
Jul 13, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
318 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1- Arm 4 (previously 1)
    Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10\^11 PFU) and oral TMP/SMX on D1 through D3.
  • Experimental: Part 1- Arm 5 (previously 2)
    Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10\^10 PFU) and oral TMP/SMX on D1 through D3.
  • Experimental: Part 1- Arm 6 (previously 3)
    Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 infusion (1x10\^12 PFU) and oral TMP/SMX on D1 through D3.
  • Experimental: Part 2: LBP-EC01
    LBP-EC01 given by dose regimen selected from Part 1. IU LBP-EC01 on D1 and D2 with IV LBP-EC01 (1x10\^11 PFU) and oral TMP/SMX on D1 through D3.
  • Placebo Comparator: Part 2: Placebo
    Placebo given by dose regimen selected from Part 1. IU placebo on D1 and D2 with IV placebo and oral TMP/SMX on D1 through D3.

Primary Outcome Measure

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 [ Time Frame: Day 1 to Day 5 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Research Site 138FresnoCalifornia93710-
Research Site 131LancasterCalifornia93534
J. Truong, MD
Research Site 123Los AngelesCalifornia90027
J. Kowalczyk
Research Site 125MontebelloCalifornia90640-
Research Site 152MurrietaCalifornia92563
M. Reddy, MD
Research Site 137San DiegoCalifornia92037
L. Burnett, MD
Research Site 126TustinCalifornia92780
L. Gabal
Research Site 102DoralFlorida33166
B. Penafiel
Research Site 151HialeahFlorida33013
C. Sacasa
Research Site 140Jensen BeachFlorida34957-
Research Site 103MiamiFlorida33176
Y. Rodriguez
Research Site 149MiamiFlorida33176
M. Ramos
Research Site 153OcalaFlorida34473
L. Alvarado, MD
Research Site 120BostonMassachusetts02115-
Research Site 154St LouisMissouri63141-
Research Site 145RaleighNorth Carolina27708
N. Siddiqui, MD
Research Site 118Winston-SalemNorth Carolina27157-

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