Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

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NCT00195351

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Study Location
Mobile, Alabama, 36617, United States
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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.
Appendicitis, Cholecystitis, Cross Infection, Diverticulitis, Peritonitis
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

- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.

- Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.

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


- Cancer


- Medicines that suppress the immune system


- Dialysis

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Appendicitis, Cholecystitis, Cross Infection, Diverticulitis, PeritonitisStudy Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
NCT00195351
  1. Mobile, Alabama
  2. Laguna Hills, California
  3. Los Angeles, California
  4. Orange, California
  5. Palm Springs, California
  6. San Diego, California
  7. Torrance, California
  8. Denver, Colorado
  9. Denver, Colorado
  10. Hartford, Connecticut
  11. Newark, Delaware
  12. Washington, District of Columbia
  13. Miami, Florida
  14. Atlanta, Georgia
  15. Honolulu, Hawaii
  16. Chicago, Illinois
  17. Indianapolis, Indiana
  18. Indianapolis, Indiana
  19. Boston, Massachusetts
  20. Springfield, Massachusetts
  21. West Roxbury, Massachusetts
  22. Detroit, Michigan
  23. Grand Rapids, Michigan
  24. Minneapolis, Minnesota
  25. St. Louis, Missouri
  26. St. Louis, Missouri
  27. Butte, Montana
  28. Lincoln, Nebraska
  29. Laconia, New Hampshire
  30. Buffalo, New York
  31. Bismarck, North Dakota
  32. Fargo, North Dakota
  33. Cleveland, Ohio
  34. Columbus, Ohio
  35. Columbus, Ohio
  36. Toledo, Ohio
  37. Zanesville, Ohio
  38. Pittsburgh, Pennsylvania
  39. Corsiana, Texas
  40. Fort Worth, Texas
  41. Houston, Texas
  42. Houston, Texas
  43. Salt Lake City, Utah
  44. Charlottesville, Virginia
  45. Madison, Wisconsin
  46. Milwaukee, Wisconsin
  47. Buenos Aires,
  48. Buenos Aires,
  49. Buenos Aires,
  50. Curitiba, PR
  51. Sao Paulo, SP
  52. Sao Paulo, SP
  53. Calgary, Alberta
  54. Victoria, British Columbia
  55. Ajax, Ontario
  56. Oshawa, Ontario
  57. Toronto, Ontario
  58. Toronto, Ontario
  59. Chicoutimi, Quebec
  60. Greenfield Park, Quebec
  61. Montreal, Quebec
  62. Rimouski, Quebec
  63. Trois-Rivieres, Quebec
  64. Santiago,
  65. Vina del Mar,
  66. Mexico D.F. CP,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Official Title  ICMJE A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
Brief Summary This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Appendicitis
  • Cholecystitis
  • Cross Infection
  • Diverticulitis
  • Peritonitis
Intervention  ICMJE
  • Drug: tigecycline
    every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
  • Drug: ceftriaxone sodium + metronidazole
    Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: tigecycline
  • Active Comparator: B
    Intervention: Drug: ceftriaxone sodium + metronidazole
Publications * Towfigh S, Pasternak J, Poirier A, Leister H, Babinchak T. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 10.1111/j.1469-0691.2010.03122.x.

*   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: April 16, 2009)		467
Original Enrollment  ICMJE
 (submitted: September 16, 2005)		430
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
  • Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

  • Cancer
  • Medicines that suppress the immune system
  • Dialysis
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 Argentina,   Brazil,   Canada,   Chile,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195351
Other Study ID Numbers  ICMJE 3074A1-400
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

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