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RECRUITING Phase 2

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

NCT05488340 · View on ClinicalTrials.gov ↗

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

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

1 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Locus Biosciences, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05488340 reports 17 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05488340?

This trial is sponsored by Locus Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial