Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia
2009年11月23日 更新者:TaiGen Biotechnology Co., Ltd.
A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP)
This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia(CAP)
研究概览
详细说明
Community-acquired Pneumonia(CAP) remains a leading cause of death in both developing and developed countries.
In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity.
TG-873870(Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.
This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP) .
研究类型
介入性
注册 (预期的)
264
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Benomi、南非
- Benmed/Pentagon Hospital
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Cape Town、南非
- MediTrials
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Kimberley、南非
- Private
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Krugersdorp、南非
- DJW Research
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Port Elizabeth、南非
- GCT Trial Centre, Mercantile Hospital
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Potchefstroom、南非
- Private
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Pretoria、南非
- Bougainville Hospital
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Scottburgh、南非
- de Villers Clinical Trials
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Witbank、南非
- Park Medical Centre
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North West
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Temba、North West、南非
- GCT at Jubilee Hospital
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Changhua、台湾、114
- Chang-Hua Christian Hospital
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Kaohsiung、台湾、114
- E-DA Hospital
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Kaoshiung、台湾、114
- Kaoshiung Medical University Hospital
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Taichung、台湾、114
- Cheng Ching Hospital
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Taichung、台湾、114
- Taichung Veterans General Hospital
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Tainan、台湾、114
- Chi-Mei Foundation Hospital
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Taipei、台湾、114
- Tri-Service General Hospital
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Taipei、台湾、114
- Buddhist Taipei Tzu Chi General Hospital
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Taipei、台湾、114
- Taipei Veterans General Hospital
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Taoyuan、台湾、114
- Chang-Gung Memorial Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
- Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact
- Must have a clinical diagnosis of CAP based on clinical evidence
- Must have a chest radiograph demonstrating new or persistent/progressive infiltrates
- Must be able to produce sputum
Exclusion Criteria:
- Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
- Patients with CAP that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with ICU support
- Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease [COPD] is not exclusionary)
- Infection acquired in a hospital, nursing home, or other long-term care facility, or hospitalization for any reason within the previous 14 days
- Treatment with any antibiotics within the past 7 days prior to randomization, unless documents to be a treatment failure(72 hours treatment and not responding)
- Anticipation of the requirement for additional treatment with non-study antibacterials for any reason during the patient's participation in the study
- Treatment with chemotherapeutic agents or oncolytics during the 6 months prior to randomization or anticipated requirement for such agents during the course of the study
- Known or suspected CNS disorder that may predispose the patient to seizures or lower the seizure threshold
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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安全评价
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Clinical Cure Rate
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次要结果测量
结果测量 |
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Bacteriologic Cure Rate
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Reury-Perng Perng, Doctor、Taipei Veterans General Hospital, Taipei, Taiwan
- 首席研究员:Ming-Lin Ho, Doctor、Chang-Hua Christian Hospital, Changhua, Taiwan
- 首席研究员:Wann-Cherng Perng, Doctor、Tri-Service General Hospital, Taipei, Taiwan
- 首席研究员:Kai-Ming Chang, Doctor、Taichung Veterans General Hospital, Taichung, Taiwan
- 首席研究员:Yen-Hsu Chen, Doctor、Kaoshiung Medical University Hospital, Kaoshiung, Taiwan
- 首席研究员:Ren-Guang Wu, Doctor、Cheng Ching Hospital, Taichung, Taiwan
- 首席研究员:Yin-Ching Chuang, Doctor、Chi-Mei Foundation Hospital, Tainan, Taiwan
- 首席研究员:Horng-Chyuan Lin, Doctor、Chang-Gung Memorial Hospital, Taoyuan, Taiwan
- 首席研究员:Yao-Kuang Wu, Doctor、Buddhist Taipei Tzu Chi General Hospital, Taipei, Taiwan
- 首席研究员:Hsi-Hsun Lin, Doctor、E-Da Hospital, Kaohsiung, Taiwan
- 首席研究员:AJ Bester, Doctor、GCT at Jubilee Hospital, RSA
- 首席研究员:J Breedt, Doctor、Bougainville Hospital, RSA
- 首席研究员:CT de Villiers, Doctor、de Villers Clinical Trials, RSA
- 首席研究员:M Gani, Doctor、GCT Trial Centre, Mercantile Hospital, RSA
- 首席研究员:Y Kelfkens, Doctor、Private, RSA
- 首席研究员:DJ Jansen van Rensburg, Doctor、Park Medical Centre, RSA
- 首席研究员:J Jurgens, Doctor、DJW Research, RSA
- 首席研究员:IH Mitha, Doctor、Benmed/Pentagon Hospital, RSA
- 首席研究员:JH Mynhardt, Doctor、Private, RSA
- 首席研究员:G Nieuwoudt, Doctor、MediTrials, RSA
- 首席研究员:J Kasumba, Doctor、JOSHA Research, RSA
- 首席研究员:E van Nieuwenhuizen, Doctor、Eastmed Clinical Trial Center, RSA
- 首席研究员:CJJ van Rensburg, Doctor、Private, RSA
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bartlett JG, Breiman RF, Mandell LA, File TM Jr. Community-acquired pneumonia in adults: guidelines for management. The Infectious Diseases Society of America. Clin Infect Dis. 1998 Apr;26(4):811-38. doi: 10.1086/513953.
- Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. doi: 10.1086/380488. Epub 2003 Nov 3. No abstract available.
- Bartlett JG, Dowell SF, Mandell LA, File TM Jr, Musher DM, Fine MJ. Practice guidelines for the management of community-acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000 Aug;31(2):347-82. doi: 10.1086/313954. Epub 2000 Sep 7. No abstract available.
- Fujimoto T, Mitsuhashi S. In vitro antibacterial activity of DR-3355, the S-(-)-isomer of ofloxacin. Chemotherapy. 1990;36(4):268-76. doi: 10.1159/000238777.
- Croom KF, Goa KL. Levofloxacin: a review of its use in the treatment of bacterial infections in the United States. Drugs. 2003;63(24):2769-802. doi: 10.2165/00003495-200363240-00008.
- Ellner PD, Neu HC. The inhibitory quotient. A method for interpreting minimum inhibitory concentration data. JAMA. 1981 Oct 2;246(14):1575-8. doi: 10.1001/jama.246.14.1575.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年12月1日
初级完成
2022年12月7日
研究完成 (实际的)
2007年8月1日
研究注册日期
首次提交
2007年2月12日
首先提交符合 QC 标准的
2007年2月12日
首次发布 (估计)
2007年2月13日
研究记录更新
最后更新发布 (估计)
2009年11月25日
上次提交的符合 QC 标准的更新
2009年11月23日
最后验证
2009年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
TG-873870(Nemonoxacin)的临床试验
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TaiGen Biotechnology Co., Ltd.完全的
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TaiGen Biotechnology Co., Ltd.R&G Pharma Studies Co.,Ltd.完全的
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TG Therapeutics, Inc.Memorial Sloan Kettering Cancer Center完全的