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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: Recruiting Phase 2 study of Urinary Tract Infections, sponsored by Locus Biosciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The regimen for LBP-EC01 when used concomitantly with TMP/SMX which optimizes pharmacokinetics (PK) for LBP-EC01 will be selected.
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
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05488340 shows while recruiting
NCT05488340 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, below the 449-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (29% lower).
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 lists 17 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT05488340's enrollment target sits among peer trials
318 14th of 34 higher than 21 of 34 other Urinary Tract Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Tract Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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