A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) (NCT05488340)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Research Site 138 โ Fresno, California
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (17 Sites)
- Research Site 138 โ Fresno, California
- Research Site 131 โ Lancaster, California
- Research Site 123 โ Los Angeles, California
- Research Site 125 โ Montebello, California
- Research Site 152 โ Murrieta, California
- Research Site 137 โ San Diego, California
- Research Site 126 โ Tustin, California
- Research Site 102 โ Doral, Florida
- Research Site 151 โ Hialeah, Florida
- Research Site 140 โ Jensen Beach, Florida
- Research Site 103 โ Miami, Florida
- Research Site 149 โ Miami, Florida
- Research Site 153 โ Ocala, Florida
- Research Site 120 โ Boston, Massachusetts
- Research Site 154 โ St Louis, Missouri
- Research Site 145 โ Raleigh, North Carolina
- Research Site 118 โ Winston-Salem, North Carolina
๐ Contact the Study Coordinator
Phone: (919) 495-4510
Email: clinicaloperations@locus-bio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urinary Tract Infections
- To Wipe or Not To Wipe?: That Is The Question โ Iowa City, Iowa
- Chlorhexidine Lavage for Recurrent Urinary Tract Infection โ Portland, Oregon
- Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery โ Boston, Massachusetts
- Prophylactic Antibiotics for Outpatient Urethral Bulking โ Miami, Florida
- Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting โ Cleveland, Ohio
Explore by condition: All Urinary Tract Infections clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.