Urinary Tract InfectionsPhase 2ELIMINATENCT05488340
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
A Phase 2 study testing LBP-EC01 0.1 x IV dose, LBP-EC01 0.01x IV Dose and LBP-EC01 IV Infusion Dose in people with Urinary Tract Infections, run by Locus Biosciences at 17 sites in United States.
Trial summary
This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- LBP-EC01 0.1 x IV dose, LBP-EC01 0.01x IV Dose and LBP-EC01 IV Infusion Dose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 17 sitesUnited States
- Study dates
- 13 Jul 2022to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli (as single pathogen or part of polymicrobial infection where E. coli is the predominant pathogen). Please note that the current infection can be used to meet the requirement of AMR E. coli documentation.
- Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
- Active acute uUTI infection defined by:
- Evidence of pyuria: i. >10 white blood cell (WBC)/mL3 on microscopic evaluation of spun, clean, mid-stream urine specimen or >3 WBC/high power field on unspun clean, mid-stream urine specimen, AND/OR ii. Dipstick analysis of a clean, mid-stream urine specimen positive for leukocytes, AND b. At least 2 of the following signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, or suprapubic pain
- Willing to comply with all aspects of study design including study restrictions, blood, urine, and stool sampling, and scheduled study visits.
- All sexually active female patients of childbearing potential must use highly effective contraception during the study and until 2 weeks after the last dose of study drug treatment.
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- Agrees to STOP continuous low dose antimicrobial prophylaxis and/or will maintain the same practices for post-coital antimicrobial prophylaxis to prevent UTI, as during the prior 12-months, for the entire study duration (throughout the 6-month follow-up period or study discharge).
- Agrees 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.
- Capable of providing their own signed informed consent form (ICF) prior to any study-related procedures being performed.
- If participating in Part 1 of the study, agrees to fast for ≥2 h prior to first dose of study drug on Day 1/Visit 1 except for drinking 240 mL of water with study drug administration.
Who cannot join
- Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/ Celsius, shaking chills, or other clinical manifestations suggestive of complicated UTI.
- Treatment with other antibacterial drugs including those that are effective for treatment of the acute uUTI or prevention of recurrent UTI in the 5 days prior to Screening unless the recovered pathogen demonstrates resistance to the initial antibiotic and clinical symptoms persist. In postmenopausal women vaginal estrogen replacement therapy is permitted so long as patient meets all other eligibility criteria, that the dose and regimen has be stable for > 3 months from Screening (D1/V1), and that there is no planned change to therapy through the 6-month follow-up period or study discontinuation.
- Clinical symptoms for more than 5 days before Screening.
- Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities that increase UTI risk or lead to a post void residual (PVR) urine volume > 150mL, poorly controlled diabetes mellitus (diagnosed but is not being treated/managed by a physician's care or HbA1c >8), current symptomatic or larger than 5mm renal calculi, or advanced renal dysfunction (determined by eGFR < 45 mL/min/1.73 m2). Patients with vaginal prolapse beyond the hymen with Valsalva (e.g., when coughing).
- Individuals considered to be immunocompromised.
- Clinically significant serious unstable physical illness that in the investigator's opinion prevents patient from completing the study or prevents interpretation or resolution of clinical symptoms.
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- Pregnant or nursing women.
- Exposure to any investigational drugs or other phage therapy 30 days prior to Screening (D1/V1) or prior to participation in this study. Patients who participate in Part 1 are not eligible for participation in Part 2.
- Allergies to excipients of the study drug or antibiotics.
- History of autonomic dysreflexia.
- History of intravenous (IV) drug abuse or is currently using or has positive results for drugs of abuse at screening.
- Patients who reside in a long-term care facility.
- Suspected or confirmed acute coronavirus disease 2019 (COVID-19) or recent COVID-19 infection with ongoing symptoms.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 12 recruiting
- Completed
Research Site 120
Boston, Massachusetts, 02115
- Recruiting
Research Site 102
Doral, Florida, 33166
B. Penafiel
- Completed
Research Site 138
Fresno, California, 93710
- Recruiting
Research Site 151
Hialeah, Florida, 33013
C. Sacasa
- Completed
Research Site 140
Jensen Beach, Florida, 34957
- Recruiting
Research Site 131
Lancaster, California, 93534
J. Truong, MD
- Recruiting
Research Site 123
Los Angeles, California, 90027
J. Kowalczyk
- Recruiting
Research Site 103
Miami, Florida, 33176
Y. Rodriguez
- Recruiting
Research Site 149
Miami, Florida, 33176
M. Ramos
- Completed
Research Site 125
Montebello, California, 90640
- Recruiting
Research Site 152
Murrieta, California, 92563
M. Reddy, MD
- Recruiting
Research Site 153
Ocala, Florida, 34473
L. Alvarado, MD
- Recruiting
Research Site 145
Raleigh, North Carolina, 27708
N. Siddiqui, MD
- Recruiting
Research Site 137
San Diego, California, 92037
L. Burnett, MD
- Recruiting
Research Site 154
St Louis, Missouri, 63141
- Recruiting
Research Site 126
Tustin, California, 92780
L. Gabal
- Completed
Research Site 118
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2, Double-blind, Randomized, Active-controlled Evaluation of the Safety, Tolerability, Pharmacokinetics and Efficacy of LBP-EC01 in the Treatment of Acute Uncomplicated Urinary Tract Infection Caused by Drug Resistant E. Coli
This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.
Read the detailed description
This study will consist of two parts.
Part 1 - Dose regimen selection: An open-label, 30 patient, 3-arm PK assessment of: Arm 4 (previously 1): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^11 PFU) IV given as a 1 milliliter (mL) bolus QD from D1 through D3 concomitantly with oral trimethoprim/sulfamethoxazole (TMP 160mg/SMX 800mg) BID from D1 through D3 (6 doses); Arm 5 (previously 2): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^10 PFU) IV given as a 1 mL bolus QD from D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses); Arm 6 (previously 3): LBP-EC01 (2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^12 PFU) IV given as a 100 mL IV infusion over 2 h on D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses).
Part 2 - Efficacy, Safety, Tolerability and Pharmacokinetics: A blinded, 288 patient, 1:1 randomized evaluation of the Arm 4 dose regimen, selected from Part 1, versus placebo + antibiotic (TMP/SMX -160 mg TMP and 800 mg SMX) given orally BID on Days 1 through 3.
- Conditions
- Urinary Tract Infections
- Being tested
- LBP-EC01 0.1 x IV dose, LBP-EC01 0.01x IV Dose, LBP-EC01 IV Infusion Dose, Placebo, LBP-EC01
- Keywords
- LBP-EC01, Urinary tract infection, E. coli, Bacteriophage, Phage, crPhage, Recombinant bacteriophage
- Medical subject headings
- Urinary Tract Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBP-EC01 0.1 x IV doseDrug
Also called 1x10^11 PFU IV dose
Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.6mL of LBP-EC01 (approximately 1x10^11 PFU) diluted in 0.4mL of Lactated Ringer's solution given on Days 1 through Day 3.
LBP-EC01 0.01x IV DoseDrug
Also called 1x10^10 PFU IV Dose
Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.06 mL of LBP-EC01 (approximately 1x10^10 PFU) diluted in 0.94 mL of Lactated Ringer's solution given on Days 1 through Day 3.
LBP-EC01 IV Infusion DoseDrug
Also called 1x10^12 PFU IV Infusion Dose
Intraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous infusion dose of 6mL of LBP-EC01 (approximately 1x10^12 PFU) diluted in 94 mL of Lactated Ringer's solution given over 2 hours on Days 1 through Day 3.
PlaceboDrug
Dose regimen selected from Part 1 of placebo (Tris buffer).
LBP-EC01Drug
Dose regimen selected from Part 1 of LBP-EC01 (1x10^10 - 1x10^13 PFU) per dose.
TMP/SMXDrug
TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.
| Study group | Role | What they receive |
|---|---|---|
| Part 1- Arm 4 (previously 1) | Experimental | Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10^11 PFU) and oral TMP/SMX on D1 through D3. Receives: Drug: LBP-EC01 0.1 x IV dose; Drug: TMP/SMX |
| Part 1- Arm 5 (previously 2) | Experimental | Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10^10 PFU) and oral TMP/SMX on D1 through D3. Receives: Drug: LBP-EC01 0.01x IV Dose; Drug: TMP/SMX |
| Part 1- Arm 6 (previously 3) | Experimental | Intraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 infusion (1x10^12 PFU) and oral TMP/SMX on D1 through D3. Receives: Drug: LBP-EC01 IV Infusion Dose; Drug: TMP/SMX |
| Part 2: LBP-EC01 | Experimental | LBP-EC01 given by dose regimen selected from Part 1. IU LBP-EC01 on D1 and D2 with IV LBP-EC01 (1x10^11 PFU) and oral TMP/SMX on D1 through D3. Receives: Drug: LBP-EC01; Drug: TMP/SMX |
| Part 2: Placebo | Placebo comparator | Placebo given by dose regimen selected from Part 1. IU placebo on D1 and D2 with IV placebo and oral TMP/SMX on D1 through D3. Receives: Drug: Placebo; Drug: TMP/SMX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The regimen for LBP-EC01 when used concomitantly with TMP/SMX which optimizes pharmacokinetics (PK) for LBP-EC01 will be selected.
Measured: Day 1 to Day 5
Part 2: Proportion of patients with resolution of clinical symptoms and microbiologic response of uUTI caused by drug resistant E. coli as defined at Day 10 test of cure (TOC).
The efficacy of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on resolution of acute uUTI clinical symptoms and demonstration of microbiologic response (CCMR) of acute uUTI caused by drug resistant E. coli will be assessed.
Measured: Day 10
Secondary outcomes (6)
Part 1: Number of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of LBP-EC01 when given with TMP/SMX will be assessed.
Measured: Day 1 to Day 34
Part 1: Number of patients with immunogenicity
The immunogenicity of LBP-EC01 by measuring neutralizing antibody (NAb) levels will be assessed.
Measured: Baseline Day 1 to Day 2, Day 5, Day 10, Day 34/Early Termination [ET]) post-hoc
Part 2: Proportion of patients with antimicrobial drug resistant (AMR) E. coli achieving maintenance of combined clinical and microbiologic response (CCMR) at Day 21.
The impact of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on maintenance of CCMR success in those randomized patients with AMR E. coli uUTI demonstrating an initial response will be assessed.
Measured: Day 21
Part 2: Proportion of patients with CCMR of uUTI caused by E. coli at Day 10/TOC.
The efficacy of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX, on CCMR of uUTI caused by E. coli (irrespective of drug resistant status) will be assessed.
Measured: Day 10
Part 2: Proportion of patients with CCMR of uUTI caused by multi-drug resistant (MDR) E. coli at Day 10/TOC.
The impact of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on CCMR in patients with uUTI caused by MDR E. coli at Day 10/TOC.
Measured: Day 21
Part 2: Proportion of patients with MDR E. coli achieving maintenance of CCMR at Day 21.
The impact of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on the maintenance of CCMR in patients with uUTI caused by MDR E. coli at Day 21.
Measured: Within the 6-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start13 Jul 2022
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Locus Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Paul Kim, Study director, Locus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488340
- Sponsor's protocol ID
- LBx-2001
- Other IDs
- 75A50120C00169
- Acronym
- ELIMINATE
- Status last verified
- Sep 2026
- First submitted
- 2 Aug 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim P, Sanchez AM, Penke TJR, Tuson HH, Kime JC, McKee RW, Slone WL, Conley NR, McMillan LJ, Prybol CJ, Garofolo PM. Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail, in uncomplicated urinary tract infections due to Escherichia coli (ELIMINATE): the randomised, open-label, first part of a two-part phase 2 trial. Lancet Infect Dis. 2024 Dec;24(12):1319-1332. doi: 10.1016/S1473-3099(24)00424-9. Epub 2024 Aug 9.
PubMed 39134085
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Active-controlled Evaluation of the Safety, Tolerability, Pharmacokinetics and Efficacy of LBP-EC01 in the Treatment of Acute Uncomplicated Urinary Tract Infection Caused by Drug Resistant E. Coli
- ClinicalTrials.gov ID
- NCT05488340
- Acronym / sponsor ID
- ELIMINATE / LBx-2001
- Conditions
- Urinary Tract Infections
- Keywords
- LBP-EC01, Urinary tract infection, E. coli, Bacteriophage, Phage, crPhage, Recombinant bacteriophage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Locus BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.
Detailed description
This study will consist of two parts.
Part 1 - Dose regimen selection: An open-label, 30 patient, 3-arm PK assessment of: Arm 4 (previously 1): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^11 PFU) IV given as a 1 milliliter (mL) bolus QD from D1 through D3 concomitantly with oral trimethoprim/sulfamethoxazole (TMP 160mg/SMX 800mg) BID from D1 through D3 (6 doses); Arm 5 (previously 2): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^10 PFU) IV given as a 1 mL bolus QD from D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses); Arm 6 (previously 3): LBP-EC01 (2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^12 PFU) IV given as a 100 mL IV infusion over 2 h on D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses).
Part 2 - Efficacy, Safety, Tolerability and Pharmacokinetics: A blinded, 288 patient, 1:1 randomized evaluation of the Arm 4 dose regimen, selected from Part 1, versus placebo + antibiotic (TMP/SMX -160 mg TMP and 800 mg SMX) given orally BID on Days 1 through 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1- Arm 4 (previously 1) | Experimental | Drug: LBP-EC01 0.1 x IV dose, Drug: TMP/SMXIntraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10^11 PFU) and oral TMP/SMX on D1 through D3. |
| Part 1- Arm 5 (previously 2) | Experimental | Drug: LBP-EC01 0.01x IV Dose, Drug: TMP/SMXIntraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 (1x10^10 PFU) and oral TMP/SMX on D1 through D3. |
| Part 1- Arm 6 (previously 3) | Experimental | Drug: LBP-EC01 IV Infusion Dose, Drug: TMP/SMXIntraurethral (IU) LBP-EC01 on D1 and D2 with intravenous (IV) LBP-EC01 infusion (1x10^12 PFU) and oral TMP/SMX on D1 through D3. |
| Part 2: LBP-EC01 | Experimental | Drug: LBP-EC01, Drug: TMP/SMXLBP-EC01 given by dose regimen selected from Part 1. IU LBP-EC01 on D1 and D2 with IV LBP-EC01 (1x10^11 PFU) and oral TMP/SMX on D1 through D3. |
| Part 2: Placebo | Placebo comparator | Drug: Placebo, Drug: TMP/SMXPlacebo given by dose regimen selected from Part 1. IU placebo on D1 and D2 with IV placebo and oral TMP/SMX on D1 through D3. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli (as single pathogen or part of polymicrobial infection where E. coli is the predominant pathogen). Please note that the current infection can be used to meet the requirement of AMR E. coli documentation.
- Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
- Active acute uUTI infection defined by:
- Willing to comply with all aspects of study design including study restrictions, blood, urine, and stool sampling, and scheduled study visits.
- All sexually active female patients of childbearing potential must use highly effective contraception during the study and until 2 weeks after the last dose of study drug treatment.
Key exclusion criteria (13 listed)
- Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/ Celsius, shaking chills, or other clinical manifestations suggestive of complicated UTI.
- Treatment with other antibacterial drugs including those that are effective for treatment of the acute uUTI or prevention of recurrent UTI in the 5 days prior to Screening unless the recovered pathogen demonstrates resistance to the initial antibiotic and clinical symptoms persist. In postmenopausal women vaginal estrogen replacement therapy is permitted so long as patient meets all other eligibility criteria, that the dose and regimen has be stable for > 3 months from Screening (D1/V1), and that there is no planned change to therapy through the 6-month follow-up period or study discontinuation.
- Clinical symptoms for more than 5 days before Screening.
- Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities that increase UTI risk or lead to a post void residual (PVR) urine volume > 150mL, poorly controlled diabetes mellitus (diagnosed but is not being treated/managed by a physician's care or HbA1c >8), current symptomatic or larger than 5mm renal calculi, or advanced renal dysfunction (determined by eGFR < 45 mL/min/1.73 m2). Patients with vaginal prolapse beyond the hymen with Valsalva (e.g., when coughing).
- Individuals considered to be immunocompromised.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBP-EC01 0.1 x IV doseAlso: 1x10^11 PFU IV doseIntraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.6mL of LBP-EC01 (approximately 1x10^11 PFU) diluted in 0.4mL of Lactated Ringer's solution given on Days 1 through Day 3. | Drug | Part 1- Arm 4 (previously 1) |
| LBP-EC01 0.01x IV DoseAlso: 1x10^10 PFU IV DoseIntraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous (IV) dose of 0.06 mL of LBP-EC01 (approximately 1x10^10 PFU) diluted in 0.94 mL of Lactated Ringer's solution given on Days 1 through Day 3. | Drug | Part 1- Arm 5 (previously 2) |
| LBP-EC01 IV Infusion DoseAlso: 1x10^12 PFU IV Infusion DoseIntraurethral (IU) dose of two (2) x 6mL vials of LBP-EC01 (approximately 2x10^12 PFU) diluted in 188 mL of Lactated Ringer's solution on Day 1 and Day 2. Intravenous infusion dose of 6mL of LBP-EC01 (approximately 1x10^12 PFU) diluted in 94 mL of Lactated Ringer's solution given over 2 hours on Days 1 through Day 3. | Drug | Part 1- Arm 6 (previously 3) |
| PlaceboDose regimen selected from Part 1 of placebo (Tris buffer). | Drug | Part 2: Placebo |
| LBP-EC01Dose regimen selected from Part 1 of LBP-EC01 (1x10^10 - 1x10^13 PFU) per dose. | Drug | Part 2: LBP-EC01 |
| TMP/SMXTMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3. | Drug | Part 1- Arm 4 (previously 1), Part 1- Arm 5 (previously 2), Part 1- Arm 6 (previously 3), Part 2: LBP-EC01, Part 2: Placebo |
Primary outcome
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
Time frame: Day 1 to Day 5
The regimen for LBP-EC01 when used concomitantly with TMP/SMX which optimizes pharmacokinetics (PK) for LBP-EC01 will be selected.
Part 2: Proportion of patients with resolution of clinical symptoms and microbiologic response of uUTI caused by drug resistant E. coli as defined at Day 10 test of cure (TOC).
Time frame: Day 10
The efficacy of LBP-EC01 when used concomitantly with TMP/SMX compared to placebo when used concomitantly with TMP/SMX on resolution of acute uUTI clinical symptoms and demonstration of microbiologic response (CCMR) of acute uUTI caused by drug resistant E. coli will be assessed.
6 secondary outcomes
Part 1: Number of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 34
Part 1: Number of patients with immunogenicity
Time frame: Baseline Day 1 to Day 2, Day 5, Day 10, Day 34/Early Termination [ET]) post-hoc
Part 2: Proportion of patients with antimicrobial drug resistant (AMR) E. coli achieving maintenance of combined clinical and microbiologic response (CCMR) at Day 21.
Time frame: Day 21
Part 2: Proportion of patients with CCMR of uUTI caused by E. coli at Day 10/TOC.
Time frame: Day 10
Part 2: Proportion of patients with CCMR of uUTI caused by multi-drug resistant (MDR) E. coli at Day 10/TOC.
Time frame: Day 21
Part 2: Proportion of patients with MDR E. coli achieving maintenance of CCMR at Day 21.
Time frame: Within the 6-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 39134085Kim P, Sanchez AM, Penke TJR, Tuson HH, Kime JC, McKee RW, Slone WL, Conley NR, McMillan LJ, Prybol CJ, Garofolo PM. Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail, in uncomplicated urinary tract infections due to Escherichia coli (ELIMINATE): the randomised, open-label, first part of a two-part phase 2 trial. Lancet Infect Dis. 2024 Dec;24(12):1319-1332. doi: 10.1016/S1473-3099(24)00424-9. Epub 2024 Aug 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Kim study director
Locus Biosciences
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LBP-EC01 0.1 x IV dose, LBP-EC01 0.01x IV Dose and LBP-EC01 IV Infusion Dose in people with Urinary Tract Infections, run by Locus Biosciences at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Locus Clinical Operations ((919) 495-4510, clinicaloperations@locus-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 1 to Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.