NCT03354598已完成3 期
A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,671
- 试验地点
- 1
- 主要终点
- Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
研究概览
简要总结
This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
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 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
- •Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
- •A mid-stream urine specimen with:
- •a dipstick analysis positive for nitrite AND
- •evidence of pyuria as defined by either:
- •i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine
- •Has given written informed consent to participate in the study.
排除标准
- •Presence of signs and symptoms suggestive of acute pyelonephritis: 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
- •Patients with ileal loops or urinary stoma
- •Patients with an indwelling urinary catheter in the previous 30 days
- •Patients with paraplegia
- •Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
- •Any history of trauma to the pelvis or urinary tract
- •Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
- •Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
- •Known history of creatinine clearance <50 mL/min
- •Patients known to have liver disease
- •Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
- •Patients with uncontrolled diabetes mellitus
- •Patients with history of blood dyscrasias
- •Patients with history of uric acid kidney stones
- •Patients with acute gouty attack
- •Patients on chronic methotrexate therapy
- •Patient known to be immunocompromised
- •Patients with a known history of myasthenia gravis
- •Patients who require concomitant administration of tizanidine or valproic acid
- •Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid
- •Patient is considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
- •History of seizures
- •Use of any other investigational drug in the 30 days prior to the study
研究组 & 干预措施
Sulopenem-etzadroxil/probenecid
Experimental
Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days
干预措施: Sulopenem-Etzadroxil/Probenecid (Drug)
Ciprofloxacin
Active Comparator
Ciprofloxacin 250 mg PO administered twice daily for 3 days
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
时间窗: Day 12+/-1 day
Overall Success: 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)
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
时间窗: Day 12 +/- 1 day
Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)
次要结局
- Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success(Day 12+/-1 day)
研究者
研究点 (1)
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相关资讯
FDA Approves Oral Sulopenem (Orlynvah) for Uncomplicated Urinary Tract Infections• The FDA has approved oral sulopenem (Orlynvah) for uncomplicated urinary tract infections (uUTIs), offering a new treatment option amid rising antimicrobial resistance.
• Clinical trials SURE 1 and REASSURE demonstrated Orlynvah's superiority over ciprofloxacin in quinolone-resistant infections and a better response rate compared to amoxicillin/clavulanate.
• Orlynvah represents the first oral penem approved in the US, providing an alternative for patients with difficult-to-treat uUTIs and addressing the unmet need for novel antibiotics.
• Post-market monitoring will be crucial to prevent off-label use and ensure responsible utilization of this new antimicrobial agent in the face of increasing resistance.last yearFDA Approves Sulopenem Etzadroxil/Probenecid (Orlynvah) for Uncomplicated UTIs• The FDA has approved sulopenem etzadroxil and probenecid (Orlynvah) for uncomplicated urinary tract infections (uUTIs) in adult women with limited oral treatment options.
• Backed by Phase 3 SURE 1 and REASSURE trials, Orlynvah demonstrated efficacy against _E. coli, K. pneumoniae_, and _P. mirabilis_, including antibiotic-resistant strains.
• As the first oral penem approved in the US, Orlynvah offers a novel alternative in the underserved uUTI market, addressing a critical need for new treatment options.
• The drug is administered orally twice daily for 5 days but is not indicated for complicated UTIs or intra-abdominal infections.last yearFDA Approves Oral Sulopenem Etzadroxil and Probenecid (Orlynvah) for Uncomplicated UTIs• The FDA has approved sulopenem etzadroxil and probenecid (Orlynvah) for uncomplicated urinary tract infections (uUTIs) in adult women with limited oral antibacterial options.
• The approval was based on the SURE 1 trial, where sulopenem etzadroxil and probenecid showed superiority to ciprofloxacin in overall response rates.
• The REASSURE study demonstrated non-inferiority of sulopenem etzadroxil and probenecid compared to amoxicillin and clavulanic acid for uUTI treatment.
• Orlynvah offers a novel oral penem option to combat antimicrobial resistance in uUTI treatment, addressing an underserved market need.last year