Clinical trial NCT01721408: A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Official title: A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections In Hospitalized Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intra-abdominal Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-04
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.


Eligibility criteria: Inclusion Criteria:

* Hospitalized male or female subjects, at least 18 year of age.
* Complicated intra-abdominal infection is present at most under two weeks duration.
* Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.

Exclusion Criteria:

* Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
* Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
* Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.

Primary outcomes:
measure: Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population
timeFrame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
measure: Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population
timeFrame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Secondary outcomes:
measure: Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population
timeFrame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
measure: Microbiological Response at the Subject Level in the ME Population at the TOC Assessment
timeFrame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness
timeFrame: From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)
Locations:
city: Anqing
country: China
facility: Anqing City Hospital
state: Anhui
city: Xicheng District
country: China
facility: Department of Hepatobiliary Surgery, Peking University People's Hospital
state: Beijing
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Guangzhou
country: China
facility: Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
city: GuangZhou
country: China
facility: The First Affiliated Hospital of JiNan University/General Surgery
state: Guangdong
city: Shantou
country: China
facility: The First Hospital of Shantou University School of Medicine
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hosptial/Department of hepatobiliary surgery
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Haikou
country: China
facility: HaiKou Municipal People's Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Provincial People's Hospital
state: Hainan
city: Sanya
country: China
facility: The Third People's Hospital of Hainan Province/department of general surgery
state: Hainan
city: Wuhan
country: China
facility: Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University/Intensive Care Unit
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central-South University/General Surgery
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University/Department of General Surgery
state: Hunan
city: Changsha
country: China
facility: The Third Hospital of Changsha/Department of Surgery
state: Hunan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Jiangyin
country: China
facility: The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Yangzhou
country: China
facility: Yangzhou No.1 People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University/Surgery
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Bin Zhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Fengxian District Central Hospital, Department of Surgery
state: Shanghai
city: Chengdu
country: China
facility: Department of General Surgery, Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Region of PLA
state: Sichuan
city: Kunming
country: China
facility: First people's Hospital of Kunming
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital/Intensive Care Unit
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: China Meitan General Hospital/General Surgery Department
city: Beijing
country: China
facility: Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University
city: Beijing
country: China
facility: Navy General Hospital PLA China/Genaral Surgery Department
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Department of General Surgery, Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Institute of Antibiotics, Hua Shan Hospital, Fudan University
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,
city: Tianjin
country: China
facility: Tianjin Union Medical Center
city: Tianjin
country: China
facility: Department of General Surgery, Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chen Y, Zhu D, Zhang Y, Zhao Y, Chen G, Li P, Xu L, Yan P, Hickman MA, Xu X, Tawadrous M, Wible M. A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China. Ther Clin Risk Manag. 2018 Nov 30;14:2327-2339. doi: 10.2147/TCRM.S171821. eCollection 2018.