- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191148
Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli
A Multi-Center Randomized, Double-Blind Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
-
Anniston, Alabama, United States, 36207
- Pinnacle Research Group
-
-
California
-
Irvine, California, United States, 92612
- Tilda Research
-
-
Florida
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Doral, Florida, United States, 33166
- Universal Axon Clinical Research
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Homestead, Florida, United States, 33030
- Universal Axon - Homestead, LL
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Miami Gardens, Florida, United States, 33169
- AMPM Research Clinic
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Palmetto Bay, Florida, United States, 45209
- Innovation Medical Research Center
-
-
South Carolina
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Charleston, South Carolina, United States, 29401
- Ralph H. Johnson VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Males or females 18 years of age or older.
Patients with a lower urinary tract colonization caused by E. coli (≥10^3 CFU/mL) and who meet at least one of the following criteria:
- Has an indwelling urinary catheter and medical documentation of a urinary tract infection by E. coli within the past 12 months
- Requires intermittent catheterization and medical documentation of a urinary tract infection by E. coli within the past 12 months
- Has medical documentation of a history of asymptomatic bacteriuria (i.e., lower urinary tract colonization) with E. coli at least once in the past 12 months
- Patients must have experience with urinary catheterization or have Medical Monitor approval if the patient does not have prior experience with catheterization.
- In good general health as evidenced by medical history and physical examination.
- Women of childbearing potential and men with female partners of childbearing potential must use two forms of effective contraception, at least 1 of which is a physical barrier method, during the study and which is recommended to continue for 2 weeks after completing the study.
Exclusion Criteria:
- Patients with clinical signs of active UTI or other infection requiring antimicrobial treatment. These may include dysuria, urinary frequency, urinary urgency, suprapubic discomfort and flank pain in addition to non-specific symptoms of urinary leakage, change in voiding habits, worsening muscle spasm, increasing autonomic dysreflexia, sweating, malaise, and fever or hypothermia. Analgesic use is permitted.
Patients who have received Gram-negative bacteria antimicrobials within 14 days of randomization.
Note: Patients who are currently only receiving antibiotics with only Gram-positive activity (e.g., vancomycin, daptomycin, linezolid) to treat active infections against Gram-positive non-UTIs can be included in the trial.
- Presence of a surgically-modified bladder, except for a repaired ruptured bladder.
- History of severe autonomic dysreflexia, which is defined as those patients who have a spinal cord injury and who have had a documented sudden increase in systolic blood pressure of greater than 40 mm Hg due to an irritation or stimulation (including bladder or bowel irritation) below the level of the spinal cord injury. Autonomic dysreflexia can include findings of hypertensive crisis or emergency, clinically significant bradycardia/tachycardia, severe headache or other severe reaction requiring an acute intervention, so consultation with the Medical Monitor should take place if a history of severe autonomic dysreflexia is suspected but not clearly identified.
- Active severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease per the investigator's discretion.
- Any malignancies within the past 5 years (except those in remission).
- Unless deemed acceptable by the Investigator, prescription drugs, over-the-counter (OTC) medications and supplements that acidify the urine are excluded.
- Patients who have had allergic reactions to similar compounds, or any excipients.
- Participation in an investigational drug or device study within 1 month (or 7 half-lives of drug, whichever is longer) prior to randomization.
- Patients who are pregnant or expecting to conceive, are breast feeding or are planning to breast feed, within 1 month of completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LBP-EC01
crPhage cocktail
|
crPhage cocktail: at approximately 1.5 x 10^10 to 3.0 x 10^10 PFU/vial dosed BID by intraurethral administration
|
Placebo Comparator: Placebo
Lactated Ringer's solution, injection, USP
|
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-related Adverse Events as Assessed by DAIDS v2.1
Time Frame: 35 days
|
Safety and tolerability of LBP-EC01: Number of participants with treatment-related adverse events as assessed by DAIDS v2.1
|
35 days
|
Pharmacokinetics of LBP-EC01: Cmax
Time Frame: 28 days
|
Maximum concentration determined directly from the concentration-time profile
|
28 days
|
Pharmacokinetics of LBP-EC01: Tmax
Time Frame: 28 days
|
Time to maximum concentration
|
28 days
|
Pharmacokinetics of LBP-EC01: AUC
Time Frame: 28 days
|
Area under the concentration versus time curve from time 0 to the last measurable concentration
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 28 days
|
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.
|
28 days
|
Time to 1 Logarithmic Reduction in Urinary E.Coli Count From Baseline
Time Frame: 28 days
|
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
|
28 days
|
Recurrence of E.Coli Colonization or Incidence of Infection Based on Clinical Signs and Symptoms
Time Frame: 28 days
|
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
|
28 days
|
Changes in Immunoglobulin (Ig)A
Time Frame: 28 days
|
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgA
|
28 days
|
Changes in IgE
Time Frame: 28 days
|
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
|
28 days
|
Changes in IgG
Time Frame: 28 days
|
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)
|
28 days
|
Changes in IgM
Time Frame: 28 days
|
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)
|
28 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBx-1001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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