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

Last updated: February 20, 2013
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Overall Status: Completed

Phase

4

Condition

Liver Disease

Liver Disorders

Appendicitis

Treatment

N/A

Clinical Study ID

NCT00195351
3074A1-400
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of complicated intra-abdominal infection that requires surgerywithin 24 hours.

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

Exclusion

Exclusion Criteria:

  • Cancer

  • Medicines that suppress the immune system

  • Dialysis

Study Design

Total Participants: 467
Study Start date:
September 01, 2005
Estimated Completion Date:
February 29, 2008

Connect with a study center

  • Buenos Aires, C1431FWO
    Argentina

    Site Not Available

  • Curitiba, PR 80810-050
    Brazil

    Site Not Available

  • Sao Paulo, SP 04330-020
    Brazil

    Site Not Available

  • Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Victoria, British Columbia V8T 5G4
    Canada

    Site Not Available

  • Ajax, Ontario L1S 2J5
    Canada

    Site Not Available

  • Oshawa, Ontario L1H 1B9
    Canada

    Site Not Available

  • Toronto, Ontario M1E 5E9
    Canada

    Site Not Available

  • Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Montreal, Quebec H2X 3J4
    Canada

    Site Not Available

  • Rimouski, Quebec G5L 5T1
    Canada

    Site Not Available

  • Trois-Rivieres, Quebec G8Z 3R9
    Canada

    Site Not Available

  • Santiago,
    Chile

    Site Not Available

  • Vina del Mar,
    Chile

    Site Not Available

  • Mexico D.F. CP, 03100
    Mexico

    Site Not Available

  • Mobile, Alabama 36617
    United States

    Site Not Available

  • Laguna Hills, California 92653
    United States

    Site Not Available

  • Los Angeles, California 90033
    United States

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  • Orange, California 92868
    United States

    Site Not Available

  • Palm Springs, California 92262
    United States

    Site Not Available

  • San Diego, California 92134
    United States

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  • Torrance, California 90509
    United States

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  • Denver, Colorado 80262
    United States

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  • Hartford, Connecticut 06102
    United States

    Site Not Available

  • Newark, Delaware 19718
    United States

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  • Washington, District of Columbia 20037
    United States

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  • Miami, Florida 33136
    United States

    Site Not Available

  • Atlanta, Georgia 30342
    United States

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  • Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Chicago, Illinois 60612
    United States

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  • Indianapolis, Indiana 46280
    United States

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  • Boston, Massachusetts 02118
    United States

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  • Springfield, Massachusetts 01199
    United States

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  • West Roxbury, Massachusetts 02132
    United States

    Site Not Available

  • Detroit, Michigan 48201
    United States

    Site Not Available

  • Grand Rapids, Michigan 49506
    United States

    Site Not Available

  • Minneapolis, Minnesota 55422
    United States

    Site Not Available

  • St. Louis, Missouri 63131
    United States

    Site Not Available

  • Butte, Montana 59701
    United States

    Site Not Available

  • Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Laconia, New Hampshire 03246
    United States

    Site Not Available

  • Buffalo, New York 14215
    United States

    Site Not Available

  • Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Fargo, North Dakota 58122
    United States

    Site Not Available

  • Cleveland, Ohio 44109
    United States

    Site Not Available

  • Columbus, Ohio 43215
    United States

    Site Not Available

  • Toledo, Ohio 43608
    United States

    Site Not Available

  • Zanesville, Ohio 43701
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania 15261
    United States

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  • Corsiana, Texas 75151
    United States

    Site Not Available

  • Fort Worth, Texas 76135
    United States

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  • Houston, Texas 77030
    United States

    Site Not Available

  • Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Charlottesville, Virginia 22906
    United States

    Site Not Available

  • Madison, Wisconsin 53792
    United States

    Site Not Available

  • Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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