Clinical Trial
Open access

Disease: Urinary Tract Infections, UTI, (NCT04191148)

Disease info:

Urinary tract infections (UTIs) are bacterial infections affecting the urinary system, which includes the kidneys, ureters, bladder, and urethra. These infections most commonly involve the bladder and urethra, causing inflammation and discomfort. UTIs are the second most common type of infection in the body.

UTIs are generally caused by bacteria, with Escherichia coli (E. coli) being the most common cause. Risk factors like diabetes, bladder catheterization, or spinal cord injuries may increase susceptibility.
UTIs can occur in anyone but are notably more common in women, who are four times more likely to experience them than men. Risk is higher in individuals with conditions such as diabetes, those using catheters, or those with spinal cord injuries.

Symptoms of a UTI include pain or burning during urination, frequent and urgent need to urinate, pressure in the lower abdomen, cloudy or reddish urine, and bad-smelling urine. Less common symptoms may include fever, tiredness, shakiness, back pain, or nausea.

 

Frequency:
UTIs can occur in anyone but are notably more common in women, who are four times more likely to experience them than men. Risk is higher in individuals with conditions such as diabetes, those using catheters, or those with spinal cord injuries.
Official title:
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
Who:
Partners:
Locations:

United States, Alabama

Pinnacle Research Group, Anniston, Alabama, United States, 36207

 

United States, California

Tilda Research, Irvine, California, United States, 92612

 

United States, Florida

Universal Axon Clinical Research, Doral, Florida, United States, 33166

Universal Axon - Homestead, LL, Homestead, Florida, United States, 33030

AMPM Research Clinic, Miami Gardens, Florida, United States, 33169

Innovation Medical Research Center, Palmetto Bay, Florida, United States, 45209

 

United States, South Carolina

Ralph H. Johnson VA Medical Center, Charleston, South Carolina, United States, 29401

Study start:
Dec. 30, 2019
Enrollment:
36 participants
Gene editing method:
CRISPR-Cas3
Gene:
E.coli genome
Delivery method:
crPhage cocktail - In-vivo
Note:
Phase 2/3 of this trial is continued in NCT05488340.
Misc:
The mechanism makes LBP-EC01 effective in killing E. coli strains regardless of whether they are resistant to antibiotics.
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

Description

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 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.

Last updated: Jan. 9, 2025
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