LBP-EC01 for Urinary Tract Infection

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Urinary Tract Infection+1 MoreLBP-EC01 - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it's better than placebo at treating urinary tract infections caused by E. coli.

Eligible Conditions
  • Urinary Tract Infection
  • Urinary Tract Infection (UTI) caused by E. Coli.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Within the 6-month follow-up period

Day 34
Part 1: Number of patients with immunogenicity
Day 34
Part 1: Number of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 5
Part 1: Levels of LBP-EC01 in urine and blood measured by quantitative plaquing assay across the treatment period and over 48 h after the last dose
Day 10
Part 2: Proportion of patients with resolution of clinical symptoms of a uncomplicated urinary tract infection (uUTI) and microbiologic response of uUTI caused by multidrug resistant or multidrug resistance (MDR) E. coli as defined at Day 10
Escherichia coli
Day 21
Part 2: Proportion of patients with E. coli achieving maintenance of clinical and microbiologic response at Day 21
Part 2: Proportion of patients with MDR E. coli achieving maintenance of clinical and microbiologic response at Day 21
Within the 6-month follow-up period
Part 2: Proportion of patients with recurrence of uUTI episodes caused by E. coli within a 6-month follow-up period

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

LBP-EC01
21%Headache
21%Urinary tract infections
13%Back pain
8%Vomiting
8%Pollakiuria
8%Dysuria
8%Dizziness
8%Hematuria
8%Rhinorrhea
4%Pneumonitis
4%Arthralgia
4%Spleen palpable
This histogram enumerates side effects from a completed 2020 Phase 1 trial (NCT04191148) in the LBP-EC01 ARM group. Side effects include: Headache with 21%, Urinary tract infections with 21%, Back pain with 13%, Vomiting with 8%, Pollakiuria with 8%.

Trial Design

8 Treatment Groups

Part 1- Arm 6 (previously 3)
1 of 8
Part 1- Arm 4 (previously 1)
1 of 8
Part 1- Arm 5 (previously 2)
1 of 8
Part 2: LBP-EC01
1 of 8
Part 1- Arm 3
1 of 8
Part 1- Arm 1
1 of 8
Part 1- Arm 2
1 of 8
Part 2: Placebo
1 of 8

Experimental Treatment

Non-Treatment Group

580 Total Participants · 8 Treatment Groups

Primary Treatment: LBP-EC01 · Has Placebo Group · Phase 2 & 3

Part 1- Arm 6 (previously 3)Experimental Group · 2 Interventions: LBP-EC01 IV Infusion Dose, TMP/SMX · Intervention Types: Drug, Drug
Part 1- Arm 4 (previously 1)Experimental Group · 2 Interventions: LBP-EC01 0.1 x IV dose, TMP/SMX · Intervention Types: Drug, Drug
Part 1- Arm 5 (previously 2)Experimental Group · 2 Interventions: LBP-EC01 0.01x IV Dose, TMP/SMX · Intervention Types: Drug, Drug
Part 2: LBP-EC01Experimental Group · 2 Interventions: LBP-EC01, TMP/SMX · Intervention Types: Drug, Drug
Part 1- Arm 3Experimental Group · 3 Interventions: LBP-EC01, Calcium carbonate, TMP/SMX · Intervention Types: Drug, Drug, Drug
Part 1- Arm 1Experimental Group · 2 Interventions: LBP-EC01, TMP/SMX · Intervention Types: Drug, Drug
Part 1- Arm 2Experimental Group · 2 Interventions: LBP-EC01, TMP/SMX · Intervention Types: Drug, Drug
Part 2: PlaceboPlaceboComparator Group · 2 Interventions: Placebo, TMP/SMX · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LBP-EC01
2019
Completed Phase 1
~40
Calcium carbonate
2012
Completed Phase 3
~4370

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within the 6-month follow-up period

Who is running the clinical trial?

ParexelIndustry Sponsor
278 Previous Clinical Trials
95,541 Total Patients Enrolled
Locus BiosciencesLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Paul KimStudy DirectorLocus Biosciences

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a female of childbearing potential and are sexually active.
You agree to not use any prescription or non-prescription medication for the microbiological or symptomatic treatment of the presenting acute uUTI for the first 10 days of the study.
You are capable of providing your own signed informed consent form (ICF) prior to any study-related procedures being performed.
You have a positive urine culture with presence of MDR OR ESBL E
You are able to supply a mid-stream, clean catch urine sample for microbiological analysis.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Research Site 106100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%
Average response time
  • < 1 Day
Most responsive sites:
  1. Research Site 106: < 24 hours