NCT00665327已完成4 期
A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 401
- 主要终点
- Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings
研究概览
简要总结
This study was to assess the safety of sequential intravenous (IV)/oral (PO) moxifloxacin (Avelox®) compared with sequential IV/PO levofloxacin (Levaquin®) in the treatment of elderly subjects (aged ≥ 65 years) with community-acquired pneumonia (CAP) who required initial IV therapy. This study also included an assessment of the clinical and bacteriologic effectiveness of both drugs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of radiological evidence of a new or progressive infiltrate(s) consistent with bacterial pneumonia and at least 2 of the following:
- •Productive cough with purulent or mucopurulent sputum/tracheobronchial secretions or change in the character of sputum (increased volume or purulence)
- •Dyspnea or tachypnea
- •Rigors or chills- Pleuritic chest pain
- •Auscultatory findings on pulmonary examination of rales/crackles and/or evidence of pulmonary consolidation- Fever or hypothermia
- •White blood cell count >/= 10000/mm3 or >/= 15% immature neutrophils, regardless of the peripheral WBC count, or leukopenia with total WBC count < 4500/mm3
排除标准
- •Known hypersensitivity to fluoroquinolones- Presence of end-organ damage or shock with need for vasopressors for > 4 hours at the time of study entry
- •Need for mechanical ventilation at study entry
- •Implanted cardiac defibrillator.- Significant bradycardia with heart rate < 50 beats/minute.
- •Hospitalized for > 48 hours before developing pneumonia.
- •Systemic antibacterial therapy for more than 24 hours within 7 days of enrollment unless the patient was deemed a treatment failure after receiving greater than 72 hours of a non-fluoroquinolone antibiotic.
- •Co-existent disease considered likely to affect the outcome of the study (e.g. active lung cancer, connective tissue disease affecting the lungs, bronchiectasis).
- •Mechanical endobronchial obstruction (e.g. endobronchial tumor).
- •Known or suspected active tuberculosis or endemic fungal infection
- •Neutropenia (neutrophil count < 1000/Microliter).
- •Chronic treatment (equal or longer than 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent).
- •Patient with known HIV infection and a CD4 count < 200/mm3 .
- •Known severe hepatic insufficiency .
- •Renal impairment with a baseline measured or calculated serum creatinine clearance < 20 mL/min. If a recent value for a 24 hour creatinine clearance is not available then the creatinine clearance should be calculated using the Cockcroft-Gault formula .
- •Known prolongation of the QT interval or use of Class IA or Class III antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol).
- •Uncorrected hypokalemia.
- •Previous history of tendinopathy with quinolones.
- •Previously entered in this study.- Participated in any clinical investigational drug study within 4 weeks of screening.
- •Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment.
- •Patients with a history of a hypersensitivity reaction to multivitamin infusion (MVI) or pre-existing hypervitaminosis.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Arm 2
Active Comparator
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings
时间窗: First 72 hours of study participation
次要结局
- Incidence of a composite safety end point (including atrial fibrillation sustained and unsustained supraventricular tachycardia, third degree AV block and long RR pauses), based on Holter(First 72 hours of study participation)
- Adverse Events Collection(Up to 7-14 days post-therapy)
- Clinical Response(Day 3-5 during treament, 7-14 days post-therapy)
- Mortality attributable to pneumonia(7-14 days post-therapy)
- Bacteriological Response(7-14 days post-therapy)
- Overall cost of hospitalization(Up to 7-14 days post-therapy)
研究者
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