At a glance
ClinicalIndex Comparison Record- ✓History of UTI in past 12 months and prior or current uUTI caused by AMR E. coli
- ✓Active acute uUTI infection with evidence of pyuria and at least 2 UTI symptoms
- ✓Able to supply mid-stream clean catch urine sample for microbiological analysis
- ✓Willing to comply with study design including restrictions, sampling, and scheduled visits
- ✕Signs/symptoms of systemic illness such as fever >38°C, shaking chills, or complicated UTI manifestations
- ✕Treatment with antibacterial drugs in 5 days prior to screening unless resistant pathogen with persistent symptoms
- ✕Clinical symptoms for more than 5 days before screening
- ✕Indwelling urinary bladder catheters, urinary tract anatomical abnormalities, post-void residual >150mL, poorly controlled diabetes, renal calculi, advanced renal dysfunction, or vaginal prolapse beyond hymen
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05488340Phase 2RecruitingMonitorUpdated 3mo ago · Completion was 1mo agoA 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
In Brief
A Phase 2 clinical trial evaluating LBP-EC01 0.1 x IV dose, LBP-EC01 0.01x IV Dose, and 4 other interventions for Urinary Tract Infections. Currently recruiting, targeting 318 participants across 17 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.6mL of LBP-EC01 (approximately 1x10\^11 PFU) diluted in 0.4mL of Lactated Ringer's solution given on Days 1 through Day 3.
Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.06 mL of LBP-EC01 (approximately 1x10\^10 PFU) diluted in 0.94 mL of Lactated Ringer's solution given on Days 1 through Day 3.
Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10\^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous infusion dose of 6mL of LBP-EC01 (approximately 1x10\^12 PFU) diluted in 94 mL of Lactated Ringer's solution given over 2 hours on Days 1 through Day 3.
Dose regimen selected from Part 1 of placebo (Tris buffer).
Dose regimen selected from Part 1 of LBP-EC01 (1x10\^10 - 1x10\^13 PFU) per dose.
TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.