EUCTR2007-000599-18-AT进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline versus Ceftriaxone in the Treatment of Adult Subjects with Community-Acquired Pneumonia - P903-09
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Cerexa, Inc.
- 入组人数
- 626
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
- 性别
- All
入选标准
- •Subjects are required to meet the following inclusion criteria:
- •1. Males and females 18 or more years of age
- •2. Community-acquired pneumonia meeting the following criteria:
- •I. Radiographically-confirmed pneumonia (new or progressive pulmonary infiltrate(s) on chest radiograph (CXR) or chest computed tomography (CT) scan consistent with bacterial pneumonia)
- •II. Acute illness (=7 days’ duration) with at least three of the following clinical signs or symptoms consistent with a lower respiratory tract infection:
- •New or increased cough
- •Purulent sputum or change in sputum character
- •Auscultatory findings consistent with pneumonia (e.g. rales, egophony, findings of consolidation)
- •Dyspnea, tachypnea, or hypoxemia (O2 saturation <90% on room air or pO2 <60 mm Hg)
- •Fever greater than 38ºC oral (>38.5ºC rectally or tympanically) or hypothermia (<35ºC)
- •White blood cell (WBC) count greater than 10,000 cells/mm3 or less than 4,500 cells/mm3
- •Greater than 10% immature neutrophils (bands) irrespective of WBC count
- •III. PORT score greater than 71 and less than or equal to 130 (i.e. PORT Risk Class III, or IV)
- •3. The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care.
- •4. The subject’s infection would, by the standard of care, require initial treatment with IV antimicrobials.
- •5. Female subjects of child-bearing potential who are fewer than 2 years post-menopausal must agree to, and comply with, using highly effective methods of birth control (i.e. condom plus spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study.
- •6. Written informed consent, willingness, and ability to comply with all study procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. PORT score less than or equal to 70 (PORT Risk Class II), PORT score greater than 130 (PORT Risk Class V), or requiring admission to an intensive care unit
- •2. CAP suitable for outpatient therapy with an oral antimicrobial agent
- •3. Confirmed or suspected respiratory tract infections attributable to sources other than community-acquired bacterial pathogens (e.g. ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
- •4. Non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
- •5. Pleural empyema (not including sterile parapneumonic effusions)
- •6. Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant typical” bacterial pathogen (e.g. Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus (MRSA)) Subjects with risk factors for MRSA infection who have predominance of gram-positive cocci in clusters on sputum Gram’s stain should also be excluded.
- •7. Infection with an atypical organism (M. pneumoniae, C. pneumoniae, Legionella spp.) is confirmed, or suspected based upon the epidemiological context, or infection with Legionella pneumophila is confirmed by the urinary antigen test at baseline.
- •8. Previous treatment with an antimicrobial for treatment of CAP within 96 hours leading up to randomization
- •EXCEPTIONS: subjects may be eligible despite prior antimicrobial therapy if they meet the following conditions:
- •A single dose of an oral cephalosporin; amoxicillin-clavulanate or other penicillin; clarithromycin or erythromycin (note: not including longer acting macrolides/ ketolides – i.e. azithromycin or telithromycin); or IV cefotaxime (short-acting cephalosporin)
- •OR BOTH OF THE FOLLOWING:
- •Unequivocal clinical evidence of treatment failure (e.g. worsening signs and symptoms) following at least 48 hours of prior systemic antimicrobial therapy
- •Isolation of an organism resistant to the prior, systemic, antimicrobial therapy
- •9. Failure of ceftriaxone (or other third-generation cephalosporin) as therapy for this episode of CAP, or prior isolation of an organism resistant in vitro to ceftriaxone
- •10. History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
- •11. Past or current history of epilepsy or seizure disorder
- •EXCEPTIONS: well-documented febrile seizure of childhood
- •12. Requirement for concomitant antimicrobial or systemic antifungal therapy for any reason
- •EXCEPTIONS: topical antifungal or antimicrobial therapy, single oral dose of any antifungal for treatment of vaginal candidiasis
- •13. Neoplastic lung disease, cystic fibrosis, progressively fatal disease, chronic neurological disorder preventing clearance of pulmonary secretions, or life expectancy of less than or equal to 3 months
- •14. Probenecid administration within 3 days prior to initiation of study drug therapy or requirement for concomitant therapy with probenecid
- •15. Infections or conditions requiring concomitant systemic corticosteroids
- •EXCEPTIONS: the corticosteroid dose equivalent is less than 40 mg prednisone per day
- •16. Severely impaired renal function (CrCl = 30 mL/min) estimated by the Cockroft-Gault formula
- •17. Evidence of significant hepatic, hematological, or immunologic di
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