Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli
Status:
Completed
Trial end date:
2020-11-19
Target enrollment:
Participant gender:
Summary
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.