Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women (REASSURE)

Iterum Therapeutics

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infections; Cystitis

Treatments: Drug: Amoxicillin/clavulanate; Drug: Sulopenem etzadroxil/probenecid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05584657

IT001-310

Details and patient eligibility

About

Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.

Full description

IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).

Enrollment: 2,229 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI
• Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
• A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine

Exclusion criteria

• Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature > 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
• Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
• Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
• Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
• Ongoing urinary retention
• Neurogenic bladder
• Current resident of a long-term care facility
• Instrumentation of urinary tract in the previous 30 days
• An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
• Any history of trauma to the pelvis or urinary tract
• Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
• History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,229 participants in 2 patient groups

Sulopenem etzadroxil/probenecid

Experimental group

Description:

Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days

Treatment:

Drug: Sulopenem etzadroxil/probenecid

Amoxicillin/clavulanate

Active Comparator group

Description:

Amoxicillin/clavulanate PO twice daily for 5 days

Treatment:

Drug: Amoxicillin/clavulanate