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

Condition(s) targeted: Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis

Intervention: tigecycline (Drug); ceftriaxone sodium + metronidazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

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).

Official title: 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

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Clinical response in the clinically evaluable population at the Test-of-Cure visit.

Secondary outcome:

Clinical Response in the microbiologically evaluable population

Microbiological Response at the subject and pathogen levels

Overall Response defined as a combination of the Clinical Response and the Microbiological Response at the subject level

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Buenos Aires C1431FWO, Argentina

Buenos Aires C1425DUH, Argentina

Buenos Aires C1118AAT, Argentina

Vina del Mar, Chile

Santiago, Chile

Mexico D.F. CP 03100, Mexico

Mobile, Alabama 36617, United States

Calgary, Alberta T2N 2T9, Canada

Victoria, British Columbia V8T 5G4, Canada

Los Angeles, California 90033, United States

Laguna Hills, California 92653, United States

Torrance, California 90509, United States

San Diego, California 92134, United States

Palm Springs, California 92262, United States

Los Angeles, California 90033, United States

Orange, California 92868, United States

Denver, Colorado 80262, United States

Denver, Colorado 80204, United States

Hartford, Connecticut 06102, United States

Newark, Delaware 19718, United States

Washington, District of Columbia 20037, United States

Miami, Florida 33136, United States

Atlanta, Georgia 30342, United States

Honolulu, Hawaii 96813, United States

Chicago, Illinois 60612, United States

Indianapolis, Indiana 46280, United States

Indianapolis, Indiana 46202, United States

West Roxbury, Massachusetts 02132, United States

Springfield, Massachusetts 01199, United States

Boston, Massachusetts 02118, United States

Grand Rapids, Michigan 49506, United States

Detroit, Michigan 48201, United States

Minneapolis, Minnesota 55422, United States

St. Louis, Missouri 63110, United States

St. Louis, Missouri 63131, United States

Butte, Montana 59701, United States

Lincoln, Nebraska 68510, United States

Laconia, New Hampshire 03246, United States

Buffalo, New York 14215, United States

Fargo, North Dakota 58122, United States

Bismarck, North Dakota 58501, United States

Zanesville, Ohio 43701, United States

Toledo, Ohio 43608, United States

Columbus, Ohio 43210, United States

Columbus, Ohio 43215, United States

Cleveland, Ohio 44109, United States

Toronto, Ontario M1E 5E9, Canada

Oshawa, Ontario L1H 1B9, Canada

Toronto, Ontario M5T 2S8, Canada

Ajax, Ontario L1S 2J5, Canada

Curitiba, PR 80810-050, Brazil

Pittsburgh, Pennsylvania 15261, United States

Trois-Rivieres, Quebec G8Z 3R9, Canada

Chicoutimi, Quebec G7H 5H6, Canada

Greenfield Park, Quebec J4V 2H1, Canada

Montreal, Quebec H2X 3J4, Canada

Rimouski, Quebec G5L 5T1, Canada

Sao Paulo, SP 04330-020, Brazil

Sao Paulo, SP 01323-010, Brazil

Houston, Texas 77030, United States

Fort Worth, Texas 76135, United States

Houston, Texas 77026, United States

Corsiana, Texas 75151, United States

Salt Lake City, Utah 84102, United States

Charlottesville, Virginia 22906, United States

Madison, Wisconsin 53792, United States

Milwaukee, Wisconsin 53226, United States

Starting date: September 2005
Ending date: February 2008
Last updated: February 29, 2008