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

Intra-abdominal Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721408
• Other study ID #: B1811185
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2012
• Last updated: September 14, 2017
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: September 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intra-abdominal Infection
• Intraabdominal Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Anqing City Hospital	Anqing	Anhui
China	Baotou Central Hospital	Baotou	Inner Mongolia
China	China Meitan General Hospital/General Surgery Department	Beijing
China	Department of General Surgery, Peking Union Medical College Hospital	Beijing
China	Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University	Beijing
China	Navy General Hospital PLA China/Genaral Surgery Department	Beijing
China	Peking University Third Hospital	Beijing
China	Binzhou Medical University Hospital	Bin Zhou	Shandong
China	Jilin Province People's Hospital	Changchun	Jilin
China	The First Hospital of Jilin University/Surgery	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Third Hospital of Changsha/Department of Surgery	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University/Department of General Surgery	Changsha	Hunan
China	Xiangya Hospital Central-South University/General Surgery	Changsha	Hunan
China	Department of General Surgery, Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	General Hospital of Chengdu Military Region of PLA	Chengdu	Sichuan
China	Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of JiNan University/General Surgery	GuangZhou	Guangdong
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	HaiKou Municipal People's Hospital	Haikou	Hainan
China	Hainan Provincial People's Hospital	Haikou	Hainan
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department	Jiangyin	Jiangsu
China	First people's Hospital of Kunming	Kunming	Yunnan
China	Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang
China	Lishui People's Hospital/Intensive Care Unit	Lishui	Zhejiang
China	The Third People's Hospital of Hainan Province/department of general surgery	Sanya	Hainan
China	Institute of Antibiotics, Hua Shan Hospital, Fudan University	Shanghai
China	Shanghai Fengxian District Central Hospital, Department of Surgery	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,	Shanghai
China	The First Hospital of Shantou University School of Medicine	Shantou	Guangdong
China	Shenzhen Second People's Hosptial/Department of hepatobiliary surgery	Shenzhen	Guangdong
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Department of General Surgery, Tianjin Medical University General Hospital	Tianjin
China	Tianjin Nankai Hospital	Tianjin
China	Tianjin Union Medical Center	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University/Intensive Care Unit	Wuhan	Hubei
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Department of Hepatobiliary Surgery, Peking University People's Hospital	Xicheng District	Beijing
China	Qinghai Provincial People's Hospital	Xining	Qinghai
China	Yangzhou No.1 People's Hospital	Yangzhou	Jiangsu
China	Zhangzhou Municipal Hospital of Fujian Province	Zhangzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness	An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.	From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)
Primary	Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population	The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).	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)
Primary	Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population	The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).	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	Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population	The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).	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	Microbiological Response at the Subject Level in the ME Population at the TOC Assessment	The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.	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)

External Links

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