Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01721408
Other study ID # B1811185
Secondary ID
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
Health authority
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.

Study Design


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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06304779 - The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI N/A
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Completed NCT05549076 - Hellenic Registry for cIAIs (HERCO-II)
Suspended NCT04519086 - The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI >30 N/A
Completed NCT00621192 - Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections Phase 1/Phase 2
Completed NCT02533869 - The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis N/A
Completed NCT00952796 - A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections Phase 4
Completed NCT01561066 - Autologous Fibrin Glues for Fistulas Closure Phase 1
Completed NCT00630513 - T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam Phase 4
Completed NCT00488345 - Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age Phase 2
Completed NCT00481702 - A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802) Phase 3
Completed NCT04882085 - Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults Phase 4
Active, not recruiting NCT05187871 - Study for Rapid Diagnosis of Postoperative Abdominal Infection
Completed NCT02739997 - Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013) Phase 3
Recruiting NCT05127109 - The PASTDUe Nutrition Ecosystem Project (PASTDUe) Phase 4
Not yet recruiting NCT04229511 - Development of Risk Score Model and Decision Tree Algorithm for Predicting Infections With CRKp in Colonized Patients
Completed NCT00244088 - Study Evaluating the Etiology of Intra-Abdominal Infections N/A