A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
Public ClinicalTrials.gov record NCT05488340. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05488340
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 318 participants
Conditions and interventions
Conditions
Interventions
- LBP-EC01 0.1 x IV dose Drug
- LBP-EC01 0.01x IV Dose Drug
- LBP-EC01 IV Infusion Dose Drug
- Placebo Drug
- LBP-EC01 Drug
- TMP/SMX Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2022
- Primary completion
- May 31, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Mar 19, 2026
2022 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 5
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site 138 | Fresno | California | 93710 | Completed |
| Research Site 131 | Lancaster | California | 93534 | Recruiting |
| Research Site 123 | Los Angeles | California | 90027 | Recruiting |
| Research Site 125 | Montebello | California | 90640 | Completed |
| Research Site 152 | Murrieta | California | 92563 | Recruiting |
| Research Site 137 | San Diego | California | 92037 | Recruiting |
| Research Site 126 | Tustin | California | 92780 | Recruiting |
| Research Site 102 | Doral | Florida | 33166 | Recruiting |
| Research Site 151 | Hialeah | Florida | 33013 | Recruiting |
| Research Site 140 | Jensen Beach | Florida | 34957 | Completed |
| Research Site 103 | Miami | Florida | 33176 | Recruiting |
| Research Site 149 | Miami | Florida | 33176 | Recruiting |
| Research Site 153 | Ocala | Florida | 34473 | Recruiting |
| Research Site 120 | Boston | Massachusetts | 02115 | Completed |
| Research Site 154 | St Louis | Missouri | 63141 | Recruiting |
| Research Site 145 | Raleigh | North Carolina | 27708 | Recruiting |
| Research Site 118 | Winston-Salem | North Carolina | 27157 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05488340, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05488340 live on ClinicalTrials.gov.