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

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NCT01721408

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Study Location
Anqing City Hospital
Anqing, Anhui, 246003, China
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intra-abdominal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Intra-abdominal InfectionA Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection NCT01721408
  1. Anqing, Anhui
  2. Xicheng District, Beijing
  3. Xiamen, Fujian
  4. Zhangzhou, Fujian
  5. Guangzhou, Guangdong
  6. GuangZhou, Guangdong
  7. Shantou, Guangdong
  8. Shenzhen, Guangdong
  9. Guilin, Guangxi
  10. Haikou, Hainan
  11. Haikou, Hainan
  12. Sanya, Hainan
  13. Wuhan, Hubei
  14. Wuhan, Hubei
  15. Wuhan, Hubei
  16. Changsha, Hunan
  17. Changsha, Hunan
  18. Changsha, Hunan
  19. Baotou, Inner Mongolia
  20. Jiangyin, Jiangsu
  21. Suzhou, Jiangsu
  22. Suzhou, Jiangsu
  23. Yangzhou, Jiangsu
  24. Changchun, Jilin
  25. Changchun, Jilin
  26. Changchun, Jilin
  27. Xining, Qinghai
  28. Bin Zhou, Shandong
  29. Shanghai, Shanghai
  30. Chengdu, Sichuan
  31. Chengdu, Sichuan
  32. Kunming, Yunnan
  33. Hangzhou, Zhejiang
  34. Linhai, Zhejiang
  35. Lishui, Zhejiang
  36. Wenzhou, Zhejiang
  37. Beijing,
  38. Beijing,
  39. Beijing,
  40. Beijing,
  41. Beijing,
  42. Shanghai,
  43. Shanghai,
  44. Shanghai,
  45. Tianjin,
  46. Tianjin,
  47. Tianjin,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Intra-abdominal InfectionStudy Evaluating the Etiology of Intra-Abdominal Infections NCT00244088
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intra-abdominal Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Drug: Tigecycline
  • Active Comparator: Group B
    Intervention: Drug: Imipenem/cilastatin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2012)		470
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01721408
Other Study ID Numbers  ICMJE B1811185
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP