A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of Oral Omadacycline and Oral Nitrofurantoin in the Treatment of Female Adults With Cystitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 23
- 主要终点
- Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as compared to oral nitrofurantoin in the treatment of female adults with cystitis.
详细描述
Participants were randomized to receive 7 days of treatment of either omadacycline or nitrofurantoin. The End of Treatment visit, Post Therapy Evaluation visit, and Final Follow-up visit was planned within 2 days following the last dose of study drug, on Day 14 (+/- 2 days) after the first dose of study drug, and within 30 to 37 days following the first dose of study drug, respectively. The study followed a double-dummy design. To maintain the study blinding, participants assigned to omadacycline received active omadacycline tablets and over-encapsulated nitrofurantoin placebo tablets. Participants assigned to the nitrofurantoin arm received omadacycline placebo tablets and over-encapsulated active nitrofurantoin capsules.
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
- Triple (Participant, 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 participants, age 18 or older who have signed the informed consent form
- •Must have a qualifying uncomplicated urinary tract infection
- •Participants must not be pregnant at the time of enrollment
- •Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
排除标准
- •Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or sexually transmitted infection
- •Evidence of significant immunological disease
- •Has received an investigational drug within the past 30 days
- •Participants who are pregnant or nursing
研究组 & 干预措施
Omadacycline 300/300 once every 24 hours
Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
干预措施: Omadacycline tablets (Drug)
Omadacycline 450/300 once every 24 hours
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
干预措施: Omadacycline tablets (Drug)
Omadacycline 450/450 once every 24 hours
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
干预措施: Omadacycline tablets (Drug)
Omadacycline 450/450 once every 12 hours
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
干预措施: Omadacycline tablets (Drug)
Nitrofurantoin 100/100 once every 12 hours
Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
干预措施: Nitrofurantoin capsules (Drug)
结局指标
主要结局
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
时间窗: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
次要结局
- Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population)(EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days))
- Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population)(FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug))
- Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population)(EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days))
- Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population)(EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days))
- Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population)(Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug))
- Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population)(EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days))
- Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population)(FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug))
- Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)(Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug))
- Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population)(Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug))
- Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population)(FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug))
- Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population)(Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug))
- Number of Participants With a Microbiological Response at the EOT Visit (ME-EOT Population)(EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days))