A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

PHASE4CompletedINTERVENTIONAL
Enrollment

470

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Intra-abdominal Infection
Interventions
DRUG

Tigecycline

every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.

DRUG

Imipenem/cilastatin

every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.

Trial Locations (47)

100028

China Meitan General Hospital/General Surgery Department, Beijing

100038

Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University, Beijing

100044

Department of Hepatobiliary Surgery, Peking University People's Hospital, Xicheng District

100048

Navy General Hospital PLA China/Genaral Surgery Department, Beijing

100191

Peking University Third Hospital, Beijing

100730

Department of General Surgery, Peking Union Medical College Hospital, Beijing

130021

Jilin Province People's Hospital, Changchun

The First Hospital of Jilin University/Surgery, Changchun

130041

The Second Hospital of Jilin University, Changchun

200040

Institute of Antibiotics, Hua Shan Hospital, Fudan University, Shanghai

200092

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

201400

Shanghai Fengxian District Central Hospital, Department of Surgery, Shanghai

201700

Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,, Shanghai

214400

The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department, Jiangyin

215004

The Second Affiliated Hospital of Soochow University, Suzhou

215006

The First Affiliated Hospital of Soochow University, Suzhou

225001

Yangzhou No.1 People's Hospital, Yangzhou

246003

Anqing City Hospital, Anqing

256603

Binzhou Medical University Hospital, Binzhou

300000

Tianjin Union Medical Center, Tianjin

300052

Department of General Surgery, Tianjin Medical University General Hospital, Tianjin

300100

Tianjin Nankai Hospital, Tianjin

310003

The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou

317000

Taizhou Hospital of Zhejiang Province, Linhai

323000

Lishui People's Hospital/Intensive Care Unit, Lishui

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

361004

Zhongshan Hospital Xiamen University, Xiamen

363000

Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou

410008

Xiangya Hospital Central-South University/General Surgery, Changsha

410013

The Third Xiangya Hospital of Central South University/Department of General Surgery, Changsha

410015

The Third Hospital of Changsha/Department of Surgery, Changsha

430014

Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan, Wuhan

430030

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

430071

Zhongnan Hospital of Wuhan University/Intensive Care Unit, Wuhan

510120

Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University, Guangzhou

510630

The First Affiliated Hospital of JiNan University/General Surgery, Guangzhou

515041

The First Hospital of Shantou University School of Medicine, Shantou

518039

Shenzhen Second People's Hosptial/Department of hepatobiliary surgery, Shenzhen

541001

Affiliated Hospital of Guilin Medical University, Guilin

570208

HaiKou Municipal People's Hospital, Haikou

570311

Hainan Provincial People's Hospital, Haikou

572000

The Third People's Hospital of Hainan Province/department of general surgery, Sanya

610072

Department of General Surgery, Sichuan Provincial People's Hospital, Chengdu

610083

General Hospital of Chengdu Military Region of PLA, Chengdu

650011

First people's Hospital of Kunming, Kunming

810007

Qinghai Provincial People's Hospital, Xining

014000

Baotou Central Hospital, Baotou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY