A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

PHASE2RecruitingINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

July 13, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Urinary Tract Infections
Interventions
DRUG

LBP-EC01 0.1 x 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.

DRUG

LBP-EC01 0.01x 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.

DRUG

LBP-EC01 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.

DRUG

Placebo

Dose regimen selected from Part 1 of placebo (Tris buffer).

DRUG

LBP-EC01

Dose regimen selected from Part 1 of LBP-EC01 (1x10\^10 - 1x10\^13 PFU) per dose.

DRUG

TMP/SMX

TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.

Trial Locations (20)

23226

COMPLETED

Research Site 127, Richmond

27157

RECRUITING

Research Site 118, Winston-Salem

30030

COMPLETED

Research Site 119, Decatur

33166

RECRUITING

Research Site 102, Doral

33176

RECRUITING

Research Site 103, Miami

34957

RECRUITING

Research Site 140, Jensen Beach

35233

COMPLETED

Research Site 115, Birmingham

48073

COMPLETED

Research Site 114, Royal Oak

60062

COMPLETED

Research Site 117, Northbrook

77555

COMPLETED

Research Site 122, Galveston

78539

COMPLETED

Research Site 141, Edinburg

90027

RECRUITING

Research Site 123, Los Angeles

90640

RECRUITING

Research Site 125, Montebello

91910

COMPLETED

Research Site 143, Chula Vista

92037

RECRUITING

Research Site 137, San Diego

92780

RECRUITING

Research Site 126, Tustin

92868

RECRUITING

Research Site 139, Orange

93534

RECRUITING

Research Site 131, Lancaster

93710

COMPLETED

Research Site 138, Fresno

02115

COMPLETED

Research Site 120, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Locus Biosciences

INDUSTRY