Clinical Trial
Open access

Disease: Urinary Tract Infections, UTI, (NCT04191148)

Disease info:

The urinary system is the body's drainage system for removing wastes and extra water. It includes two kidneys, two ureters, a bladder, and a urethra. Urinary tract infections (UTIs) are the second most common type of infection in the body.

Symptoms of UTI include

  • Pain or burning when you urinate
  • Fever, tiredness, or shakiness
  • An urge to urinate often
  • Pressure in your lower belly
  • Urine that smells bad or looks cloudy or reddish
  • Pain in your back or side below the ribs

 

Frequency:
People of any age or sex can get UTIs, but about four times as many women get UTIs than men. You're also at higher risk if you have diabetes, need a tube to drain your bladder, or have a spinal cord injury.
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:
Sponsor:

Locus Biosciences

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
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04191148
Safety updates:

(24-02-2021) Locus Biosciences completes first-of-its-kind controlled clinical trial for CRISPR-enhanced bacteriophage therapy

Other links:

LinkUrinary Track Infection information and frequencyLinkNews Article: World's-first clinical trial for a CRISPR-Cas3 phage therapy. Interview: Joseph Nixon, Locus Biosciences.

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: Apr. 20, 2024
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