NCT00237445终止4 期
A Multinational, Multicenter, Randomized, Double-blind, Study in Areas of High Pneumococcal Resistance Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Ketek® Telithromycin Once Daily for 7 Days, or Zithromax® Azithromycin Once Daily for 5 Days
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Evaluate clinical cure rates of telithromycin over azithromycin for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high pneumococcal bacterial resistance areas, at the test of cure visit (Days 17-21).
研究概览
简要总结
A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days
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
- Double
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 outpatients aged 20 or greater.
- •Subjects with a positive Binax NOW S. pneumoniae Urinary Antigen Test and/or positive gram stain for diplococci.
- •Subjects with ≤ 7 days of signs and symptoms of CAP.
- •Subjects with chest x-ray findings that support a diagnosis of acute pneumonia with presence of a new infiltrate. For subjects with history of chronic obstructive pulmonary disease (COPD), a comparison to previous chest x-ray report is required to confirm the finding of new infiltrates.
- •Subjects with diagnosis of acute mild to moderate CAP based on at least one of the following:
- •fever (oral >37.5°C/99.5°F or axillary >37.4°C/99.4°F or rectal >38.5°C/101.5°F) or
- •elevated total peripheral white blood cell count >10,000/mm3 or >15% immature neutrophils (bands), regardless of total peripheral white count and
- •new and sudden onset (equal or less than 48 hours) of at least two of the following signs or symptoms:
- •dyspnea or tachypnea (particularly if progressive in nature)
- •pleuritic chest pain
- •purulent sputum production or change in sputum character
- •auscultatory findings (such as rales and/or evidence of pulmonary consolidation)
排除标准
- •Subjects presenting with any of the following will not be included in the study.
- •Subjects with CAP requiring hospitalization.
- •Subjects with signs and symptoms of severe CAP lasting greater than 7 days.
- •Subjects requiring parenteral antibiotic treatment.
- •Subjects discharged from hospital within the 10 days before study entry.
- •Subjects with visible/gross aspiration pneumonia.
- •Subjects with any concomitant pulmonary disease, condition or complication that could confound the interpretation or evaluation of drug efficacy or safety, including:
- •severe bronchiectasis, cystic fibrosis or suspected active pulmonary tuberculosis
- •suspected acute pulmonary embolism
- •emphysema, lung abscess, extra pulmonary extension (e.g., meningitis, septic arthritis, endocarditis)
- •known bronchial obstruction or a history of postobstructive pneumonia.
- •Subjects with neoplastic lung disease (lung cancer) or another malignancy metastatic to the lungs, and/or requiring chemotherapeutic interventions for this or other neoplasms.
- •Subjects with infection requiring administration of other systemic antimicrobial agents.
- •Subjects with progressively fatal disease; life expectancy ≤3 months.
- •Subjects with myasthenia gravis.
- •Subjects with any concomitant condition, including severe and/or uncontrolled cardiovascular, neurologic, endocrine, or other severe and/or uncontrolled major systemic disease that make implementation of the protocol or interpretation of the study results difficult.
- •Immunocompromised subjects, such as:
- •known HIV subjects with CD4+ T-lymphocyte count dated less than 3 months <200/mm3 and /or HIV subjects treated with isoniazide or clarithromycin as prophylaxis
- •neutropenia (<1500 neutrophils/mm3) not attributable to the acute infectious disease
- •metastatic or hematological malignancy
- •splenectomy or known hyposplenia or asplenia
- •chronic corticosteroid therapy.
- •Subjects with a history of congenital or a family history of long QT syndrome (if not excluded by previous ECG) and subjects with known acquired QT interval prolongation
- •Known severe impaired renal function as shown by creatinine clearance < 30 ml/min either measured or estimated with Cockroft formula.
- •Subjects who have received more than 24 hours of effective treatment with other antibiotics, within the 7 days prior to enrollment in the study.
- •Subjects with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to telithromycin or any macrolide antibiotic.
- •Subjects who will require on-study treatment with medications known to have potential drug interactions, including ergot alkaloids derivatives, terfenadine, astemizole, cisapride, pimozide, simvastatin, atorvastatin and lovastatin (see Section 6.2).
- •Subjects who have received any investigational drug within 1 month prior to study entry or such treatment is planned for during the study period.
- •Subjects who are pregnant or breast-feeding.
- •Subjects with recent drug or alcohol abuse.Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Subject is the investigator or any subinvestigator, research assistance, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •Subjects already enrolled in this study.
结局指标
主要结局
Evaluate clinical cure rates of telithromycin over azithromycin for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high pneumococcal bacterial resistance areas, at the test of cure visit (Days 17-21).
次要结局
- To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy
研究者
研究点 (2)
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