This study investigates a new treatment, LBP-EC01, for urinary tract infections (UTIs) caused by drug-resistant E. coli. A UTI is an infection in any part of the urinary system, often causing pain and discomfort. Drug-resistant means the bacteria don't respond to common antibiotics. LBP-EC01 is a recombinant bacteriophage cocktail, which is a mix of viruses that can attack bacteria.
The study has two parts. In the first part, 30 patients will help determine the best dose. In the second part, 288 patients will either receive LBP-EC01 with an antibiotic or a placebo (a look-alike pill with no active ingredient) with an antibiotic. All participants will have an acute, uncomplicated UTI at the start.
- Participation: Requires attending regular visits and following the study plan.
- Eligibility: Must have had a UTI caused by drug-resistant E. coli in the past year.
- Risks: Includes potential side effects and commitments to study rules.
Participants must agree not to use other treatments for their UTI during the study and are required to use effective birth control if applicable.