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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2025
  • participants needed
    580
  • sponsor
    Locus Biosciences
Updated on 4 October 2022
antibiotics
trimethoprim
sulfamethoxazole
urine culture
antimicrobials
dysuria
urinary urgency
cranberry extract
beta lactamase
trometamol

Summary

This is a Phase 2/3 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 550 patient 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.

Description

This study will consist of two parts.

Part 1 - Dose regimen selection: An open-label, 30 patient, 3-arm PK assessment of: Arm 1: Two (2) doses of 6mL of LBP-EC01 (1x10^10 -1x10^13 PFU) given IV 4hrs apart on Days 1 through 5 and trimethoprim (TMP)/sulfamethoxazole (SMX) (160 mg TMP and 800 mg SMX) given orally BID on Days 1 through 3; Arm 2: The same dosing regimen as Arm 1 with addition of an intravesicular administration on Day 1 of 6mL of LBP-EC01 (1x10^10 -1x10^13 PFU) diluted in 94 mL of 0.9% NaCl; Arm 3: 6mL of LBP-EC01 (1x10^10 -1x10^13 PFU)administered IV 4hrs apart on Days 1-2 followed by 6mL of LBP-EC01 taken orally with 14mL of water 4hrs apart on Days 3-5 with TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.

Part 2 - Efficacy, Safety, Tolerability and Pharmacokinetics: A blinded, 550 patient, 1:1 randomized evaluation of the dose regimen selected from Part 1 versus placebo + antibiotic (TMP/SMX -160 mg TMP and 800 mg SMX) given orally BID on Days 1 through 3.

Details
Condition Urinary Tract Infections
Treatment Placebo, Calcium Carbonate, LBP-EC01, TMP/SMX
Clinical Study IdentifierNCT05488340
SponsorLocus Biosciences
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

History of recurrent UTI defined as ≥2 UTIs in the past 6 months or ≥ 3 UTIs in the past 12 months prior to Screening (Day 1/Visit 1) with at least one of these caused by E. coli (as single pathogen or part of polymicrobial infection where E. coli was the predominant pathogen at quantitation ≥ 1.0 × 10^5 colony forming units [CFU]/mL) based on culture results/documentation
History of positive urine culture with presence of MDR OR extended spectrum beta-lactamases (ESBL) E. coli within the last 12 months
Able to supply a mid-stream, clean catch urine sample for microbiological analysis
Active acute uUTI infection defined by
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, mid-stream urine specimen, AND/OR ii. Dipstick analysis of a clean, mid-stream urine specimen positive for leukocytes, AND/OR iii. Positive catalase test of a clean, mid-stream urine specimen. AND b. At least 2 of the following signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, or suprapubic pain
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 the use of cranberry products, probiotics (Lactobacillus spp), D-mannose, OM-89 (various strains of E. coli), continuous low dose antimicrobial prophylaxis and/or post-coital antimicrobial prophylaxis to prevent UTI for the entire study duration (throughout the 6-month follow-up period or study discharge)
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

Exclusion Criteria

Pregnant or nursing women
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
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 3 days prior to Screening unless the recovered pathogen demonstrates resistance to the initial antibiotic and clinical symptoms persist
Clinical symptoms for more than 7 days before Screening
Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities, poorly-controlled diabetes mellitus, immunocompromising condition and/or treatment, or advanced renal disfunction
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
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
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
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