EUCTR2015-003026-14-DE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 860
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male and female subjects 18 years of age or older.
- •2. Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening):
- •- Production of purulent sputum consistent with a bacterial infection
- •- Difficulty breathing
- •- Chest pain due to pneumonia
- •AND have at least 2 of the following findings:
- •- Fever (oral temperature > 38.0°C or equivalent)
- •- Hypothermia (oral temperature < 35.0°C or equivalent)
- •- 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 understudy) 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/mm3
- •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.
- •4. PORT risk class of II to V
- •5. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 559
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 301
排除标准
- •1. 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.
- •2. Any infection expected to require other systemic antibacterial agents in addition to study drug.
- •3. Receipt of systemic antibiotic therapy in the 7 days before enrollment
- •- one dose of a single, potentially effective, short-acting antimicrobial drug or a short-acting antimicrobial drug or drug regimen for CABP under study within 24 hours before enrollment is allowed - limited to 25% of enrolled subjects.
- •4. Respiratory infection confirmed or suspected to be secondary to hospital-acquired or ventilator-associated pneumonia or requires treatment in an intensive care Setting, or mechanical Ventilation
- •5. 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)
- •6. Known anatomical or pathological obstruction or history of bronchiectasis or GOLD Stage 4 COPD or history of post obstructive pneumonia.
- •7. Severely compromised immune system
- •8. 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 neurpathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B Inhibitors agens and adrenergic serotonergic agents.
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