Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05488340
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2022-08-02
Brief Title:
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E Coli ELIMINATE Trial
Sponsor:
Locus Biosciences
Organization:
Locus Biosciences
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELIMINATE
Brief 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 11 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 21012 PFU given by IU administration on D1 and D2 and LBP-EC01 approximately 11011 PFU IV given as a 1 milliliter mL bolus QD from D1 through D3 concomitantly with oral trimethoprimsulfamethoxazole TMP 160mgSMX 800mg BID from D1 through D3 6 doses Arm 5 previously 2 LBP-EC01 approximately 21012 PFU given by IU administration on D1 and D2 and LBP-EC01 approximately 11010 PFU IV given as a 1 mL bolus QD from D1 through D3 concomitantly with oral TMPSMX BID from D1 through D3 6 doses Arm 6 previously 3 LBP-EC01 21012 PFU given by IU administration on D1 and D2 and LBP-EC01 approximately 11012 PFU IV given as a 100 mL IV infusion over 2 h on D1 through D3 concomitantly with oral TMPSMX BID from D1 through D3 6 doses
Part 2 - Efficacy Safety Tolerability and Pharmacokinetics A blinded 288 patient 11 randomized evaluation of the Arm 4 dose regimen selected from Part 1 versus placebo antibiotic TMPSMX -160 mg TMP and 800 mg SMX given orally BID on Days 1 through 3
Part 1 - Dose regimen selection An open-label 30 patient 3-arm PK assessment of Arm 4 previously 1 LBP-EC01 approximately 21012 PFU given by IU administration on D1 and D2 and LBP-EC01 approximately 11011 PFU IV given as a 1 milliliter mL bolus QD from D1 through D3 concomitantly with oral trimethoprimsulfamethoxazole TMP 160mgSMX 800mg BID from D1 through D3 6 doses Arm 5 previously 2 LBP-EC01 approximately 21012 PFU given by IU administration on D1 and D2 and LBP-EC01 approximately 11010 PFU IV given as a 1 mL bolus QD from D1 through D3 concomitantly with oral TMPSMX BID from D1 through D3 6 doses Arm 6 previously 3 LBP-EC01 21012 PFU given by IU administration on D1 and D2 and LBP-EC01 approximately 11012 PFU IV given as a 100 mL IV infusion over 2 h on D1 through D3 concomitantly with oral TMPSMX BID from D1 through D3 6 doses
Part 2 - Efficacy Safety Tolerability and Pharmacokinetics A blinded 288 patient 11 randomized evaluation of the Arm 4 dose regimen selected from Part 1 versus placebo antibiotic TMPSMX -160 mg TMP and 800 mg SMX given orally BID on Days 1 through 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None