IR@PKUHSC  > 北京大学第二临床医学院
学科主题临床医学
Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial
Chen, Zhangjing1; Wu, Jufang1; Zhang, Yingyuan1; Wei, Junming2; Leng, Xisheng3; Bi, Jianwei4; Li, Rong5; Yan, Lunan6; Quan, Zhiwei7; Chen, Xiaoping8; Yu, Yunsong9; Wu, Zhiyong10; Liu, Dawei11; Ma, Xiaochun12; Maroko, Robert13; Cooper, Angel13
刊名BMC INFECTIOUS DISEASES
2010-07-21
DOI10.1186/1471-2334-10-217
10
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Infectious Diseases
资助者Wyeth Research, Collegeville, PA, USA ; Wyeth Research, Collegeville, PA, USA
研究领域[WOS]Infectious Diseases
关键词[WOS]SKIN-STRUCTURE INFECTIONS ; INTENSIVE-CARE-UNIT ; IN-VITRO ACTIVITY ; BACTERIAL PATHOGENS ; VANCOMYCIN-AZTREONAM ; PHASE-3 ; PROGRAM
英文摘要

Background: Tigecycline, a first-in-class broad-spectrum glycylcycline antibiotic, has broad-spectrum in vitro activity against bacteria commonly encountered in complicated intra-abdominal infections (cIAIs), including aerobic and facultative Gram-positive and Gram-negative bacteria and anaerobic bacteria. In the current trial, tigecycline was evaluated for safety and efficacy vs. imipenem/cilastatin in hospitalized Chinese patients with cIAIs.

Methods: In this phase 3, multicenter, open-label study, patients were randomly assigned to receive IV tigecycline or imipenem/cilastatin for <= 2 weeks. The primary efficacy endpoints were clinical response at the test-of-cure visit (12-37 days after therapy) for the microbiologic modified intent-to-treat and microbiologically evaluable populations. Because the study was not powered to demonstrate non-inferiority between tigecycline and imipenem/cilastatin, no formal statistical analysis was performed. Two-sided 95% confidence intervals (CIs) were calculated for the response rates in each treatment group and for differences between treatment groups for descriptive purposes.

Results: One hundred ninety-nine patients received >= 1 dose of study drug and comprised the modified intent-to-treat population. In the microbiologically evaluable population, 86.5% (45 of 52) of tigecycline- and 97.9% (47 of 48) of imipenem/cilastatin-treated patients were cured at the test-of-cure assessment (12-37 days after therapy); in the microbiologic modified intent-to-treat population, cure rates were 81.7% (49 of 60) and 90.9% (50 of 55), respectively. The overall incidence of treatment-emergent adverse events was 80.4% for tigecycline vs. 53.9% after imipenem/cilastatin therapy (P < 0.001), primarily due to gastrointestinal-related events, especially nausea (21.6% vs. 3.9%; P < 0.001) and vomiting (12.4% vs. 2.0%; P = 0.005).

Conclusions: Clinical cure rates for tigecycline were consistent with those found in global cIAI studies. The overall safety profile was also consistent with that observed in global studies of tigecycline for treatment of cIAI, as well as that observed in analyses of Chinese patients in those studies; no novel trends were observed.

Trial Registration: ClinicalTrials.gov NCT00136201

语种英语
资助者Wyeth Research, Collegeville, PA, USA ; Wyeth Research, Collegeville, PA, USA
WOS记录号WOS:000283139500002
Citation statistics
Cited Times:28[WOS]   [WOS Record]     [Related Records in WOS]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/63386
Collection北京大学第二临床医学院
作者单位1.Fudan Univ, Huashan Hosp, Shanghai 200433, Peoples R China
2.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
3.Shanghai Changhai Hosp, Shanghai, Peoples R China
4.China PLA Gen Hosp, Beijing, Peoples R China
5.Sichuan Univ, W China Hosp, Chengdu 610064, Peoples R China
6.Shanghai Xinhua Hosp, Shanghai, Peoples R China
7.Tongji Hosp, Wuhan, Peoples R China
8.Shanghai Renji Hosp, Shanghai, Peoples R China
9.Pfizer Inc, Collegeville, PA USA
10.Beijing Union Med Coll Hosp, Beijing 100730, Peoples R China
11.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
12.Beijing Union Med Coll Hosp, Beijing, Peoples R China
13.China Med Univ, Affiliated Hosp 1, Shenyang, LiaoNing, Peoples R China
Recommended Citation
GB/T 7714
Chen, Zhangjing,Wu, Jufang,Zhang, Yingyuan,et al. Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial[J]. BMC INFECTIOUS DISEASES,2010,10.
APA Chen, Zhangjing.,Wu, Jufang.,Zhang, Yingyuan.,Wei, Junming.,Leng, Xisheng.,...&Cooper, Angel.(2010).Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial.BMC INFECTIOUS DISEASES,10.
MLA Chen, Zhangjing,et al."Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial".BMC INFECTIOUS DISEASES 10(2010).
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