A Double-blind, Randomized, Comparator-controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of ACHN-490 Injection Administered IV in Patients With Complicated Urinary Tract Infections or Acute Pyelonephritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 主要终点
- Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
研究概览
简要总结
This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented or suspected cUTI/AP with clinical signs and symptoms
- •Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula
排除标准
- •Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis
- •Gross heanaturia requiring intervention other than study drug
- •Urinary tract surgery within 7 days of randomization or during the study period
- •A known nonrenal source of infection diagnosed within 7 days of randomization
- •A corrected QT interval > 440 msec
- •History of hearing loss with onset before the age of 40 years, sensorineural hearing loss, or family history of hearing loss
- •Pregnant or breastfeeding women
研究组 & 干预措施
plazomicin (10 mg/kg)
Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo.
干预措施: plazomicin (Drug)
plazomicin (10 mg/kg)
Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo.
干预措施: placebo (Drug)
plazomicin (15 mg/kg)
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
干预措施: plazomicin (Drug)
plazomicin (15 mg/kg)
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
干预措施: placebo (Drug)
levofloxacin
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.
干预措施: levofloxacin (Drug)
levofloxacin
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
时间窗: Day 1 to TOC (Day 12)
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10\^5 colony forming unit(s) per milliliter (CFU/mL) were reduced to \<10\^4 CFU/mL.
Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population
时间窗: Day 1 to TOC (Day 12)
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10\^5 CFU/mL were reduced to \<10\^4 CFU/mL.
Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)
时间窗: Day 1 to the end of study (Day 40)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.
次要结局
- Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population(Day 1 to TOC (Day 12))
- Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population(Day 1 to TOC (Day 12))
- Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population(Day 1 to EOT (Day 5))
- Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population(Day 1 to EOT (Day 5))
- Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population(Day 1 to EOT (Day 5))
- Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen(Day 1 to TOC (Day 12))
- Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category(Day 1 to TOC (Day 12))
- Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region(Day 1 to TOC (Day 12))
- Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population(Day 1 to End of Study (Day 40))
- Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population(Day 1 to End of Study (Day 40))
- Time (Days) to Defervescense in the MITT Population(Day 1 to End of Study (Day 40))
- Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population(Day 1 to LTFU (Day 40))
- Percentage of Patients With a Superinfection or New Infection in the ME Population(Day 1 to to End of Study (Day 40))