Study LBx-1001 is a multi-center randomized, double-blind study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LBP-EC01 in patients with indwelling urinary catheters, or requiring intermittent catheterization, and/or patients with asymptomatic bacteriuria caused by Escherichia coli (E. coli). This study population has been selected because LBP-EC01 is a phage cocktail where active bacterial host engagement is required to allow for amplification of the phage and evaluation of the safety and PK of the phage cocktail. Eligible patients will require confirmation of colonization with a urine sample taken within 10 days of randomization that cultures contain ≥10\^3 E. coli colony forming unit (CFU)/mL, without the patient having clinical signs or symptoms of an active urinary tract infection (UTI) requiring antibiotic treatment. Patients should have E. coli as the primary colonizing bacteria and must not have a secondary bacterial colonization at levels equal to or greater than that seen from E. coli.
Approximately 30 patients 18 years of age or older with a history of urinary tract infection or colonization caused by E. coli who have indwelling urinary catheters, or who require intermittent catheterization, and/or patients with asymptomatic bacteriuria caused by E. coli colonization (≥10\^3 CFU/mL) on microbiological diagnosis, without clinical signs or symptoms of infection requiring antibiotic treatment will be enrolled. Patients will be screened for presence of E. coli colonization (≥10\^3 CFU/mL) prior to randomization and evaluated for potential bacterial susceptibility to LBP-EC01. Secondary Objective: To evaluate the pharmacodynamics (PD) of LBP-EC01. Exploratory Objective: To explore the influence of LBP-EC01 on the urinary tract microbiota.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
36
Pinnacle Research Group
Anniston, Alabama, United States
Tilda Research
Irvine, California, United States
Universal Axon Clinical Research
Doral, Florida, United States
Universal Axon - Homestead, LL
Homestead, Florida, United States
AMPM Research Clinic
Miami Gardens, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States
Number of Participants With Treatment-related Adverse Events as Assessed by DAIDS v2.1
Safety and tolerability of LBP-EC01: Number of participants with treatment-related adverse events as assessed by DAIDS v2.1
Time frame: 35 days
Pharmacokinetics of LBP-EC01: Cmax
Maximum concentration determined directly from the concentration-time profile
Time frame: 28 days
Pharmacokinetics of LBP-EC01: Tmax
Time to maximum concentration
Time frame: 28 days
Pharmacokinetics of LBP-EC01: AUC
Area under the concentration versus time curve from time 0 to the last measurable concentration
Time frame: 28 days
Reduction in Urinary E.Coli Burden at Any of the Following Time Points: Day 2, Day 3, Day 5, Day 7 (EOT), Day 14 and Day 28
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through reduction in urinary E.coli burden as defined by at least 1 log CFU reduction from baseline.
Time frame: 28 days
Time to 1 Logarithmic Reduction in Urinary E.Coli Count From Baseline
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through time to 1 logarithmic reduction in urinary E.coli count from baseline
Time frame: 28 days
Recurrence of E.Coli Colonization or Incidence of Infection Based on Clinical Signs and Symptoms
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through recurrence of E.Coli colonization or incidence of infection based on clinical signs and symptoms
Time frame: 28 days
Changes in Immunoglobulin (Ig)A
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgA
Time frame: 28 days
Changes in IgE
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgE with a positive detection of \>100 IU/mL
Time frame: 28 days
Changes in IgG
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgG with a positive detection of \>1600 mg/dL (\>16.0 g/L)
Time frame: 28 days
Changes in IgM
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgM with a positive detection \>230 mg/dL (\>2.3 g/L)
Time frame: 28 days
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