A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired Bacterial Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- Early Clinical Response
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin in the treatment of adult patients with community-acquired pneumonia.
详细描述
The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of community-acquired bacterial pneumonia compared with moxifloxacin, or linezolid in the case of confirmed MRSA.
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
- •Male or female 18 years of age or older
- •Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)
- •Production of purulent sputum consistent with bacterial infection
- •Difficulty breathing
- •Chest pain due to pneumonia
- •AND have at least 2 of the following findings:
- •Fever (oral temperature >38.0°C)
- •Hypothermia (oral temperature <35.0°C)
- •Tachycardia (heart rate >100 beats/min)
- •Tachypnea (respiratory rate >18 breaths/min)
- •AND have at least 1 of the following findings:
- •Hypoxemia (oxygen saturation <90% or PaO2 < 60 mmHg) on room air or with subject's baseline (pre-CABP under study) supplemental oxygen
- •Clinical evidence of pulmonary consolidation and/or presence of pulmonary rales
- •An elevated white blood cell count (WBC) >10,000/mm3 or 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with WBC <4500/mm^3
- •Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study within 48 hours before the first dose of study drug
- •PORT risk class of II to V (PSI score >50)
- •Must be a suitable candidate for possible IV to oral switch antibiotic therapy and must also be able to swallow large tablets/capsules intact without crushing
排除标准
- •A medical history of significant hypersensitivity or allergic reaction to antibiotics of the quinolone or oxazolidinone class or study drug excipients according to the investigator
- •Any infection expected to require other systemic antibiotics in addition to study drug
- •Receipt of systemic antibiotic therapy in the 7 days before enrollment unless 1 of the following is documented:
- •Received at least 48 hours of antibiotic therapy for CABP and clinic notes document treatment failure (i.e., not by patient history or pulmonary imaging alone) with new or worsening symptoms while on pre-study therapy
- •Received 1 dose of a single, potentially effective, short-acting antibacterial drug or drug regimen for CABP within 24 hours before enrollment (limited to 25% of enrolled patients)
- •Respiratory infection confirmed or suspected to be secondary to hospital-acquired or ventilator-associated pneumonia OR requires treatment in an intensive care setting, OR requires mechanical ventilation
- •Current or suspected diagnosis of viral, fungal, or aspiration pneumonia, noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, empyema (not including sterile parapneumonic effusions)
- •Known anatomical or pathological bronchial obstruction OR history of bronchiectasis OR GOLD Stage 4 COPD OR history of post obstructive pneumonia
- •Severely compromised immune system
- •Known history of Child-Pugh Class B or C liver disease
- •History of post-antibiotic colitis within last 3 months
- •Other exclusions include those described in the safety label for drugs in the quinolone and/or oxazolidinone classes such as QT prolongation, proarrhythmic conditions, concomitant use of drugs known to cause QT prolongation, peripheral neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B inhibitor agents and adrenergic serotonergic agents
研究组 & 干预措施
Delafloxacin
IV delafloxacin with potential to switch to oral delafloxacin
干预措施: Delafloxacin (Drug)
Moxifloxacin/Linezolid
IV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA
干预措施: Moxifloxacin (Drug)
Moxifloxacin/Linezolid
IV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA
干预措施: Linezolid (Drug)
结局指标
主要结局
Early Clinical Response
时间窗: 96 (+/- 24) hours after the first dose of study drug
Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.
次要结局
- Microbiologic Response(5 to 10 days after the last dose of study drug)
- Early Clinical Response Plus Improvement in Vital Signs and no Worsening of the 4 Symptoms(96 (+/- 24) hours after the first dose of study drug)
- Clinical Outcome at Test of Cure(5 to 10 days after the last dose of study drug)
- Clinical Outcome at End of Treatment(Up to 24 (+4) hours after the last dose of study drug)
- All-cause Mortality(Day 28 (+/- 2 days))