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NCT05488340 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Urinary Tract Infections, sponsored by Locus Biosciences.

Recruiting
Registry status
Phase 2
Development phase
318
Enrollment target
17
Study locations

NCT05488340 is a Phase 2 study of Urinary Tract Infections that is actively recruiting participants, run by Locus Biosciences. The registered enrollment target is 318 participants, below the 449-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (29% lower). The trial reports 17 study locations across 5 states.

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The verdict

NCT05488340, a Phase 2 study of Urinary Tract Infections, is actively recruiting participants, sponsored by Locus Biosciences.

RECRUITING
Registry status
Phase 2
Development phase
318 participants
Enrollment target
17
Study locations

Study 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.

Conditions Studied

Urinary Tract Infections

Interventions

  • DRUG Placebo
  • DRUG LBP-EC01 0.1 x IV dose
  • DRUG LBP-EC01 0.01x IV Dose
  • DRUG LBP-EC01 IV Infusion Dose
  • DRUG LBP-EC01

Study Locations (17)

California

  • Research Site 138 - Fresno
  • Research Site 131 - Lancaster
  • Research Site 123 - Los Angeles
  • Research Site 125 - Montebello
  • Research Site 152 - Murrieta
  • Research Site 137 - San Diego
  • Research Site 126 - Tustin

Florida

  • Research Site 102 - Doral
  • Research Site 151 - Hialeah
  • Research Site 140 - Jensen Beach
  • Research Site 103 - Miami
  • Research Site 149 - Miami
  • Research Site 153 - Ocala

North Carolina

  • Research Site 145 - Raleigh
  • Research Site 118 - Winston-Salem

Massachusetts

  • Research Site 120 - Boston

Missouri

  • Research Site 154 - St Louis

Trial Details

FieldValue
Enrollment Target 318 participants
Start Date 2022-07-13
Est. Completion 2026-12
Phase Phase 2

Sponsor

Locus Biosciences

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05488340

The ClinicalTrials.gov registry entry for NCT05488340 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 449-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (29% lower). The listed sponsor is Locus Biosciences, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Urinary Tract Infections appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT05488340 reports 17 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05488340 about?

NCT05488340 is a clinical study titled "A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)". 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 rando...

What is the current status of trial NCT05488340?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 318 participants. The study started on 2022-07-13. Estimated completion is 2026-12.

What conditions does trial NCT05488340 study?

This clinical trial studies the following conditions: Urinary Tract Infections.

What interventions are being tested in trial NCT05488340?

The interventions under investigation include: Placebo (DRUG), LBP-EC01 0.1 x IV dose (DRUG), LBP-EC01 0.01x IV Dose (DRUG), LBP-EC01 IV Infusion Dose (DRUG), LBP-EC01 (DRUG).

Who is sponsoring clinical trial NCT05488340?

This trial is sponsored by Locus Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05488340 being conducted?

This trial has 17 study locations across California, Florida, Massachusetts, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.