NCT06162286招募中3 期
A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-acquired Bacterial Pneumonia (CABP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 40
- 主要终点
- Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.
研究概览
简要总结
The primary objective of the study is to show that in Chinese adults with CABP, a course of IV/PO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, IV/PO moxifloxacin. The study is designed as a bridging study, to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and signed informed consent obtained before any protocol specific assessment is performed.
- •Male or female, ages 18 years or older.
- •Has at least 3 of the following symptoms:
- •Production of purulent sputum
- •Dyspnea (shortness of breath)
- •Chest pain
- •Has at least 2 of the following abnormal vital signs:
- •Fever or hypothermia documented by the investigator (temperature > 38.0°C or < 36.0°C)
- •Hypotension with systolic blood pressure (SBP) < 90 mmHg
- •Heart rate (HR) > 90 beats per minute (bpm)
- •Respiratory rate (RR) > 20 breaths/minute
排除标准
- •Has received antibacterial treatment >24hr within the 72hr window prior to randomization.
- •Subjects may be eligible despite prior antibacterial therapy if they had been treated with short action time antimicrobial for ≤24h, or if they have received > 48 hours of prior systemic antibacterial therapy for the current episode of CABP with unequivocal clinical evidence of treatment failure.
- •Is known or suspected to have CABP caused by a pathogen that may be resistant to either test article (eg, Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystis jiroveci, obligate anaerobes, mycobacteria, fungal pathogens).
- •Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess.
研究组 & 干预措施
Moxifloxacin
Active Comparator
Moxifloxacin IV/PO
干预措施: Moxifloxacin (Drug)
Omadacycline
Experimental
Omadacycline IV/PO
干预措施: Omadacycline (Drug)
结局指标
主要结局
Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.
时间窗: 18 months
次要结局
- Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.(18 months)
- Clinical response rate at the Early Clinical Response (ECR) assessment (72 to 120 hours after administration of the first dose of test article) in the mITT population.(72 to 120 hours)
研究者
研究点 (40)
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