A Multicentre, Open Label, Non-comparative, Phase 4 study to evaluate the safety and efficacy of intravenous Plazomicin for the treatment of complicated urinary tract infection (cUTI), including Acute Pyelonephritis (AP), in adults
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Cipla Ltd
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- Assessment of adverse events including serious adverse events, treatment
研究概览
简要总结
After a written, signed, dated informed consent isobtained, adult subjects with cUTI and/or AP will be screened for eligibilityto participate in the study. Patientswith a clinical diagnosis of cUTI, and/or AP, deemed to benefit from plazomicinwill receive treatment with Plazomicin IV once daily. During screening periodsamples of urine and/blood of patients will be sent for culture and antibioticsensitivity analysis while Plazomicin will be initiated. Plazomicin will becontinued for 4 to 7 days in those patients in whom culture report showssensitivity to Plazomicin [microorganism: Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis or Enterobacter cloacae]. Follow-up visits atday 14 and day 28 from first dose of the IV treatment will be conducted forthose who complete the IV treatment. Patients will be assessed throughout thetreatment period (as appropriate) and at follow-up visit. A range ofobservations will be recorded, including clinical, microbiological and safetyassessments. Adverse events will be monitored throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Parents or their legally acceptable representatives who voluntarily provide written informed consent.
- •Male or Female patients of age 18 years or older.
- •Patients with clinical diagnosis of cUTI, Including Acute Pyelonephritis (AP) suspected to be caused by susceptible microorganisms to Plazomicin vis E-Coli, Klebsiella Pneumoniae, Proteus Mirabillis, or Enterobacter cloacae will be recorded.
排除标准
- •Known hypersensitivity to any aminoglycosides or any excipients.
- •Calculated creatinine clearance at screening less than 15 ml per unit.
- •Receipt of any dose of potentially therapeutic antibacterial agent within 48 hours prior to start of study therapy.
结局指标
主要结局
Assessment of adverse events including serious adverse events, treatment
时间窗: At Baseline, Day 7, Day 14 and Day 28
emergent adverse events and nephrotoxicity
时间窗: At Baseline, Day 7, Day 14 and Day 28
次要结局
- Clinical response [cure / improvement / failure / indeterminate] at end of IV(treatment [EOIV] and follow up visit [Day 14 and Day 28])