NCT05060419Unknown2 期
Phase Ⅱ, Randomized, Double-Blind,Double-Dummy Study Evaluating Safety,Tolerability,Efficacy of Meropenem-FL058 in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 主要终点
- Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
研究概览
简要总结
Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.
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
- Double (Participant, Investigator)
盲法说明
Double-Blind,Double-Dummy
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, aged 18 ~ 75 years (inclusive);；
- •Acute pyelonephritis or other complicated urinary tract infection.
排除标准
- •Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
- •Fungal urinary tract infection;
- •History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;
- •Pregnant or breastfeeding women;
- •Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;
- •Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.
研究组 & 干预措施
Meropenem-FL058 (180min infusion)
Experimental
干预措施: Meropenem- FL058 (Drug)
Meropenem-FL058 (180min infusion)
Experimental
干预措施: Saline (Drug)
Piperacillin-Tazobactan (30min infusion)
Active Comparator
干预措施: Piperacillin -tazobactam (Drug)
Piperacillin-Tazobactan (30min infusion)
Active Comparator
干预措施: Saline (Drug)
结局指标
主要结局
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
时间窗: 5 to 9 days post-End of Treatment
Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication.
次要结局
未报告次要终点
研究者
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