Actively Recruiting
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
Led by Locus Biosciences · Updated on 2026-03-20
318
Participants Needed
17
Research Sites
228 weeks
Total Duration
On this page
Sponsors
L
Locus Biosciences
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of urinary tract infection in the past 12 months caused by antimicrobial-resistant E. coli
- Ability to provide a mid-stream, clean catch urine sample for testing
- Active acute uncomplicated urinary tract infection with evidence of pyuria and at least two symptoms such as painful urination, frequent urination, urgency, or suprapubic pain
- Willingness to follow all study rules, including blood, urine, and stool sampling and attending scheduled visits
- Use of highly effective contraception during the study and for 2 weeks after treatment if sexually active and of childbearing potential
- Agreement to stop or maintain the same low-dose antimicrobial prophylaxis practices for the entire study period
- Agreement to not use other medications for treating the current urinary tract infection for the first 10 days
- Ability to provide informed consent
- For Part 1 participants, agreement to fast for at least 2 hours before the first dose except drinking water
You will not qualify if you...
- Signs of systemic illness such as fever over 38°C, shaking chills, or other signs of complicated UTI
- Use of other antibiotics effective against the current infection within 5 days before screening unless infection is resistant and symptoms persist
- Symptoms lasting more than 5 days before screening
- Presence of urinary catheters, urinary tract abnormalities with high residual urine, uncontrolled diabetes, kidney stones larger than 5 mm, or advanced kidney dysfunction
- Vaginal prolapse beyond the hymen
- Being immunocompromised
- Serious unstable physical illness preventing study completion
- Pregnancy or nursing
- Use of investigational drugs or phage therapy within 30 days before screening
- Allergies to study drug or antibiotics
- History of autonomic dysreflexia
- History or current intravenous drug abuse or positive drug screening
- Residence in long-term care facilities
- Suspected or confirmed COVID-19 infection with ongoing symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Research Site 138
Fresno, California, United States, 93710
Completed
2
Research Site 131
Lancaster, California, United States, 93534
Actively Recruiting
3
Research Site 123
Los Angeles, California, United States, 90027
Actively Recruiting
4
Research Site 125
Montebello, California, United States, 90640
Completed
5
Research Site 152
Murrieta, California, United States, 92563
Actively Recruiting
6
Research Site 137
San Diego, California, United States, 92037
Actively Recruiting
7
Research Site 126
Tustin, California, United States, 92780
Actively Recruiting
8
Research Site 102
Doral, Florida, United States, 33166
Actively Recruiting
9
Research Site 151
Hialeah, Florida, United States, 33013
Actively Recruiting
10
Research Site 140
Jensen Beach, Florida, United States, 34957
Completed
11
Research Site 103
Miami, Florida, United States, 33176
Actively Recruiting
12
Research Site 149
Miami, Florida, United States, 33176
Actively Recruiting
13
Research Site 153
Ocala, Florida, United States, 34473
Actively Recruiting
14
Research Site 120
Boston, Massachusetts, United States, 02115
Completed
15
Research Site 154
St Louis, Missouri, United States, 63141
Actively Recruiting
16
Research Site 145
Raleigh, North Carolina, United States, 27708
Actively Recruiting
17
Research Site 118
Winston-Salem, North Carolina, United States, 27157
Completed
Research Team
L
Locus Clinical Operations
CONTACT
P
Paul Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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