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

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

IT001-310 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iterum Therapeutics, International Limited
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids; Lactams; Probenecid

Criteria

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