A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,229
- 试验地点
- 10
- 主要终点
- Overall Success
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sulopenem etzadroxil/probenecid
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
干预措施: Sulopenem etzadroxil/probenecid (Drug)
Amoxicillin/clavulanate
Amoxicillin/clavulanate PO twice daily for 5 days
干预措施: Amoxicillin/clavulanate (Drug)
结局指标
主要结局
Overall Success
时间窗: 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
时间窗: 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)
次要结局
- Clinical Success Modified Intent-to-treat Population(Day 12+/-1 day)
- Clinical Success(Day 12+/-1 day)
- Clinical Success Susceptible Population(Day 12+/-1 day)
- Microbiologic Success(Day 12+/-1 day)
- Microbiologic Success Susceptible Population(Day 12+/-1 day)