If you think you may qualify for the ELIMINATE trial, please call 833-305-6287 to perform an automated pre-screening questionnaire.
Worldwide, an estimated 150 million people are affected by Urinary Tract Infections (UTIs) each year. Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics. Nearly 40% of patients with UTIs experience a recurrence within months of the first episode. Both the U.S. Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring development of new treatments.
To address these critical, unmet medical needs, Locus Biosciences has partnered with the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services, to develop a new class of precision biotherapeutics to treat UTIs and other infections caused by E. coli.
LBP-EC01 is a clinical-stage precision investigational therapeutic designed to target E. coli infections. It is a cocktail of bacteriophages (Phages) engineered to precisely remove E. coli bacteria, which may be resistant to multiple drugs, in patients with UTIs. This product is currently being evaluated in a clinical trial for the treatment of recurrent, uncomplicated UTIs in women.
about Locus Biosciences
about how phages work
about the ELIMINATE trial
You may be eligible for the study if you meet the following criteria:
Female patients from ≥18 years to 65 years of age at Screening.
History of recurrent UTI defined as ≥2 UTIs in the past 6 months or ≥3 UTIs in the past 12 months prior to Screening, with at least one of these caused by E. coli based on culture results/documentation.
History of positive urine culture with presence of multidrug resistant E. coli within the last 12 months.
Able to supply a midstream, clean catch urine sample for microbiological analysis.
Active acute uUTI infection defined by a AND b:
a. Evidence of pyuria (presence of white blood cells in the urine):
b. At least 2 of the following signs or symptoms of UTI
i. Dysuria (pain or burning sensation while urinating)
ii. Urinary urgency
iii. Urinary frequency
iv. Suprapubic pain (near the urinary bladder)
You are not eligible for the study if you meet the following criteria:
Signs or symptoms of systemic illness such as fever greater equal to or greater than 100.4°F, shaking chills, or other clinical manifestations suggestive of complicated UTI.
Treatment with other antibacterial drugs including those that are effective for treatment of the acute UTI or prevention of recurrent UTI in the 3 days prior to Screening, unless the bacteria that are causing the UTI demonstrate resistance to the initial antibiotic and clinical symptoms persist. In postmenopausal women, vaginal estrogen replacement therapy is permitted so long as all other eligibility criteria are met and the dose and regimen has be stable for > 6 months from Screening and that there are no planned changes to therapy through the 6 month follow up period.
Clinical symptoms for more than 4 days before Screening.
Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities, poorly controlled diabetes mellitus, immunocompromising condition and/or treatment, or advanced renal (kidney) dysfunction
Individual considered to be immunocompromised.
Clinically significant serious unstable physical illness that in the investigator’s opinion prevents patient from completing the study.
Pregnant or nursing.
History of autonomic dysreflexia (a condition that occurs after a spinal cord injury which results in an abnormal, overreaction of the involuntary (autonomic) nervous system to stimulation.).
Patients with incontinence.
Reside in a long-term care facility.
Recruiting Study Sites
If you think you may qualify for the ELIMINATE trial, please call 833-305-6287 to perform an automated pre-screening questionnaire and be connected to one of the following recruiting sites.
United States, Alabama
Anniston, Alabama 36207
United States, California
Tustin, California 92780
United States, Florida
Doral, Florida 33166
Miami (Sunset), Florida 33173
Miami (Kendall), Florida 33176
Palmetto Bay, Florida 33157
United States, Texas
Forney, Texas 75126