A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
- Conditions
- Intra-abdominal Infection
- Interventions
- Drug: Imipenem/cilastatin
- Registration Number
- NCT01721408
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Imipenem/cilastatin - Group A Tigecycline -
- Primary Outcome Measures
Name Time Method Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population 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) 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).
Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population 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) 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).
- Secondary Outcome Measures
Name Time Method Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population 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) 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).
Microbiological Response at the Subject Level in the ME Population at the TOC Assessment 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) 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.
Trial Locations
- Locations (47)
Anqing City Hospital
🇨🇳Anqing, Anhui, China
Department of Hepatobiliary Surgery, Peking University People's Hospital
🇨🇳Xicheng District, Beijing, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
🇨🇳Zhangzhou, Fujian, 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
The First Hospital of Shantou University School of Medicine
🇨🇳Shantou, Guangdong, China
Shenzhen Second People's Hosptial/Department of hepatobiliary surgery
🇨🇳Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
HaiKou Municipal People's Hospital
🇨🇳Haikou, Hainan, China
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