EUCTR2007-000598-41-DE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, with Adjunctive Clarithromycin, in the Treatment of Adult Subjects with Community-Acquired Pneumonia
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
- 610
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 15% immature neutrophils (bands) irrespective of WBC count
- •III. PORT score greater than 70 and less than or equal to 130 (i.e. PORT Risk Class II, III, or IV) (see Section 9.1)
- •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 require initial treatment with IV antimicrobials.
- •5. Female subjects of child-bearing potential, and those 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
- •Subjects must NOT meet any of the following exclusion criteria:
- •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 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 active viral infection, fungal infection, active tuberculosis 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]).
- •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 or intravenous short-acting antibiotic for CAP (see Appendix 2 for a list of allowed and disallowed antibiotics)
- •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. History of any hypersensitivity or allergic reaction to clariazithromycin or any macrolide/ ketolide
- •12. Inability to take oral azithromycin, if IV azithromycin is not availableclarithromycin
- •13. Requirement for concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction with clarithromycin; or labeled contraindication to use of clarithromycin
- •14. Past or current history of epilepsy or seizure disorder
- •EXCEPTIONS: well-documented febrile seizure of childhood
- •15. 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
- •16. 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
- •17. Probenecid administration within 3 days prior to initiation of the study treatment regimen or requirement for concomitant therapy with probenecid
- •18. Infections or conditions requiring concomitant systemic corticosteroids
- •EXCEPTIONS: the corticosteroid dose equivalent is less than 40 mg prednisone per day
- •19. Severely impaired renal function (CrCl = 30 mL/min) estimated by the Cockroft-Gault formula
- •20. Evidence of significant hepatic, hematological, or immunologic
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