Phase 2 Study of LBP-EC01 Combined With Antibiotics for Treating Acute Uncomplicated Urinary Tract Infection Caused by Drug-Resistant E. Coli

What this Trial Is About

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for women with acute uncomplicated urinary tract infections UTI caused by drug-resistant E. coli. The study aims to find the best dosing regimen and compare the treatments safety, tolerability, pharmacokinetics, and effectiveness against placebo when combined with an antibiotic, trimethoprimsulfamethoxazole TMPSMX. Eligible participants must have an active acute UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts. Part 1 is an open-label dose regimen selection with 30 patients divided into three groups receiving different doses of LBP-EC01 via intraurethral and intravenous administration alongside oral TMPSMX over three days. Part 2 is a double-blind, randomized comparison of the selected LBP-EC01 dose regimen versus placebo, both with oral TMPSMX, in 288 patients. Treatment in Part 2 lasts three days, with doses given twice daily for TMPSMX and specified LBP-EC01 doses on days 1 to 3. Participants will provide urine, blood, and stool samples for microbiological and pharmacokinetic analyses. Researchers will monitor clinical symptoms, microbiologic responses, adverse events, and immunogenicity over several follow-up visits up to six months. The main outcomes include drug levels in urine and blood, symptom resolution, and microbiological cure by day 10. Safety and tolerability are also closely observed throughout the study.

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)