EUCTR2007-000598-41-BG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
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
- 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
- •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 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
- •1. PORT score less than or equal to 70 (PORT Risk Class I or 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.
- •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 nonpurulent 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. epidemiological clues to potential MRSA infection include residence in a nursing home or assisted living facility, existence of an ongiong local MRSA infection ourbreak, know skin colonization with MRSA, recent skin or skin structure infection due to MRSA, IV drug use, and concomitant influenza. Subjects with risk factors for MRSA infection who have predominance of G+ 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 penumophilla is confirmed by the urinary antigene 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:
- •EITHER: A single dose of an oral or intravenous short-acting antibiotic for CAP
- •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 associated with this episode of CAP and 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 clarithromycin or any macrolide/ ketolide
- •12. Inability to take oral clarithromycin
- •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- EXCEPTION: well-documented febrile seizure of childhood
- •15. Requirement for concomitant antimicrobial or systemic antifungal therapy for any reason. EXCEPTIONS: topical antifungal or antimicrobial therapy, a 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. EXCEPTION: the co
研究者
相似试验
进行中（未招募）
1 期
A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic ArthritisEUCTR2016-001163-37-PLJanssen-Cilag International N.V.360
进行中（未招募）
3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of SR-0379 in Participants with Skin Ulcerskin ulcerJPRN-jRCT2031210266Ichioka Shigeru120
进行中（未招募）
1 期
A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaChronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)MedDRA version: 14.1Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2011-000830-12-BEEisai Limited84
已完成
3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitischronic inflammation of the mucous membrane of the large intestineinflammatory bowel disease10017969NL-OMON47446Celgene International II Sarl (CIS II)33
已完成
3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of Linaclotide Administered Orally to Children, Ages 6 to 17 Years, With Functional Constipation (FC)and painful defecationinfrequenthard stools10002112Functional ConstipationNL-OMON52398AbbVie Deutschland GmbH & Co. KG15