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

Phase 3

Completed

• Conditions: Cystitis; Urinary Tract Infections
• Interventions: Drug: Sulopenem etzadroxil/probenecid; Drug: Amoxicillin/clavulanate

• Registration Number: NCT05584657
• Lead Sponsor: Iterum Therapeutics, International Limited

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study Start: 2022-10-18
• Study First Posted: 2022-10-18
• Primary Completion: 2023-11-03
• Study Completion: 2023-11-21
• Status Verified: 2024-10
• Results First Submitted: 2024-10-30
• Results First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Results First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2229

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulopenem etzadroxil/probenecid	Sulopenem etzadroxil/probenecid	Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Amoxicillin/clavulanate	Amoxicillin/clavulanate	Amoxicillin/clavulanate PO twice daily for 5 days

Primary Outcome Measures

Name	Time	Method
Overall Success	Day 12+/-1 day	Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Overall Success Susceptible Population	Day 12+/-1 day	Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)

Secondary Outcome Measures

Name	Time	Method
Clinical Success Modified Intent-to-treat Population	Day 12+/-1 day	Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Clinical Success	Day 12+/-1 day	Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Clinical Success Susceptible Population	Day 12+/-1 day	Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Microbiologic Success	Day 12+/-1 day	Eradication of the Baseline Pathogen
Microbiologic Success Susceptible Population	Day 12+/-1 day	Microbiologic Success: Eradication of the Baseline Pathogen

Trial Locations

Locations (10)

Medical Facility3; 🇺🇸 Sugar Land, Texas, United States

Medical Facility6; 🇺🇸 Miami, Florida, United States

Medical Facility7; 🇺🇸 Miami, Florida, United States

Medical Facility5; 🇺🇸 Tampa, Florida, United States

Medical Facility4; 🇺🇸 Tampa, Florida, United States

Medical Facility9; 🇺🇸 Miami, Florida, United States

Medical Facility8; 🇺🇸 Miami, Florida, United States

Medical Facility 2; 🇺🇸 Draper, Utah, United States

Medical Facility; 🇺🇸 Morgantown, West Virginia, United States

Medical Facility2; 🇺🇸 Plano, Texas, United States