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New treatment option for Urinary Tract Infections
Official title A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
ClinicalTrials.gov ID: NCT05488340
What this study is testing
What is LBP-EC01 0.1 x IV dose?
LBP-EC01 0.1 x IV dose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urinary tract infections.
Also referred to as 1x10^11 PFU IV dose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli (as single pathogen or part of polymicrobial infection where E...
- Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
- Active acute uUTI infection defined by: a. Evidence of pyuria: i. \>10 white blood cell (WBC)/mL3 on microscopic evaluation of spun, clean...
- Willing to comply with all aspects of study design including study restrictions, blood, urine, and stool sampling, and scheduled study visits.
- All sexually active female patients of childbearing potential must use highly effective contraception during the study and until 2 weeks after the...
You likely can't join if
- Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/ Celsius, shaking chills, or other clinical manifestations suggestive...
- Treatment with other antibacterial drugs including those that are effective for treatment of the acute uUTI or prevention of recurrent UTI in the 5...
- Clinical symptoms for more than 5 days before Screening.
- Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities that increase UTI risk or lead to a post void residual (PVR)...
- Individuals considered to be immunocompromised.
- Clinically significant serious unstable physical illness that in the investigator's opinion prevents patient from completing the study or prevents...
See the full eligibility criteria
- History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli (as single pathogen or part of polymicrobial infection where E. coli is the predominant pathogen). Please note that the current...
- Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
- Active acute uUTI infection defined by: a. Evidence of pyuria: i. \>10 white blood cell (WBC)/mL3 on microscopic evaluation of spun, clean, mid-stream urine specimen or \>3 WBC/high power field on unspun clean...
- Willing to comply with all aspects of study design including study restrictions, blood, urine, and stool sampling, and scheduled study visits.
- All sexually active female patients of childbearing potential must use highly effective contraception during the study and until 2 weeks after the last dose of study drug treatment.
- Agrees to STOP continuous low dose antimicrobial prophylaxis and/or will maintain the same practices for post-coital antimicrobial prophylaxis to prevent UTI, as during the prior 12-months, for the entire study duration...
- Agrees to not use any prescription or non-prescription medication for the microbiological or symptomatic treatment of the presenting acute uUTI for the first 10 days of the study.
- Capable of providing their own signed informed consent form (ICF) prior to any study-related procedures being performed.
- If participating in Part 1 of the study, agrees to fast for ≥2 h prior to first dose of study drug on Day 1/Visit 1 except for drinking 240 mL of water with study drug administration.
- Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/ Celsius, 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 uUTI or prevention of recurrent UTI in the 5 days prior to Screening unless the recovered pathogen demonstrates...
- Clinical symptoms for more than 5 days before Screening.
- Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities that increase UTI risk or lead to a post void residual (PVR) urine volume \> 150mL, poorly controlled diabetes mellitus (diagnosed...
- Individuals considered to be immunocompromised.
- Clinically significant serious unstable physical illness that in the investigator's opinion prevents patient from completing the study or prevents interpretation or resolution of clinical symptoms.
- Pregnant or nursing women.
- Exposure to any investigational drugs or other phage therapy 30 days prior to Screening (D1/V1) or prior to participation in this study. Patients who participate in Part 1 are not eligible for participation in Part 2.
- Allergies to excipients of the study drug or antibiotics.
- History of autonomic dysreflexia.
- History of intravenous (IV) drug abuse or is currently using or has positive results for drugs of abuse at screening.
- Patients who reside in a long-term care facility.
- Suspected or confirmed acute coronavirus disease 2019 (COVID-19) or recent COVID-19 infection with ongoing symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Montebello, California, United States
- Murrieta, California, United States
- San Diego, California, United States
- Tustin, California, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Jensen Beach, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Raleigh, North Carolina, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Lancaster, California, United States; Los Angeles, California, United States; Montebello, California, United States; Murrieta, California, United States; San Diego, California, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.