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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00195351 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Appendicitis Cholecystitis Cross Infection Diverticulitis Peritonitis |
Drug: tigecycline Drug: ceftriaxone sodium + metronidazole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 467 |
| Study Start Date: | September 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Active Comparator |
Drug: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
|
| B: Active Comparator |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile, Alabama, United States, 36617 | |
| United States, California | |
| Los Angeles, California, United States, 90033 | |
| Laguna Hills, California, United States, 92653 | |
| Torrance, California, United States, 90509 | |
| Orange, California, United States, 92868 | |
| Palm Springs, California, United States, 92262 | |
| Los Angeles, California, United States, 90033 | |
| San Diego, California, United States, 92134 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80262 | |
| Denver, Colorado, United States, 80204 | |
| United States, Connecticut | |
| Hartford, Connecticut, United States, 06102 | |
| United States, Delaware | |
| Newark, Delaware, United States, 19718 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46280 | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| West Roxbury, Massachusetts, United States, 02132 | |
| Springfield, Massachusetts, United States, 01199 | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Grand Rapids, Michigan, United States, 49506 | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55422 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| St. Louis, Missouri, United States, 63131 | |
| United States, Montana | |
| Butte, Montana, United States, 59701 | |
| United States, Nebraska | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, New Hampshire | |
| Laconia, New Hampshire, United States, 03246 | |
| United States, New York | |
| Buffalo, New York, United States, 14215 | |
| United States, North Dakota | |
| Fargo, North Dakota, United States, 58122 | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Zanesville, Ohio, United States, 43701 | |
| Toledo, Ohio, United States, 43608 | |
| Columbus, Ohio, United States, 43210 | |
| Columbus, Ohio, United States, 43215 | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Fort Worth, Texas, United States, 76135 | |
| Houston, Texas, United States, 77026 | |
| Corsiana, Texas, United States, 75151 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84102 | |
| United States, Virginia | |
| Charlottesville, Virginia, United States, 22906 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Argentina | |
| Buenos Aires, Argentina, C1431FWO | |
| Buenos Aires, Argentina, C1425DUH | |
| Buenos Aires, Argentina, C1118AAT | |
| Brazil, PR | |
| Curitiba, PR, Brazil, 80810-050 | |
| Brazil, SP | |
| Sao Paulo, SP, Brazil, 04330-020 | |
| Sao Paulo, SP, Brazil, 01323-010 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, British Columbia | |
| Victoria, British Columbia, Canada, V8T 5G4 | |
| Canada, Ontario | |
| Ajax, Ontario, Canada, L1S 2J5 | |
| Oshawa, Ontario, Canada, L1H 1B9 | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Toronto, Ontario, Canada, M1E 5E9 | |
| Canada, Quebec | |
| Trois-Rivieres, Quebec, Canada, G8Z 3R9 | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Montreal, Quebec, Canada, H2X 3J4 | |
| Rimouski, Quebec, Canada, G5L 5T1 | |
| Chile | |
| Vina Del Mar, Chile | |
| Santiago, Chile | |
| Mexico | |
| Mexico D.f. Cp, Mexico, 03100 | |
| Study Director: | Medical Monitor | Wyeth |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3074A1-400 |
| Study First Received: | September 12, 2005 |
| Results First Received: | February 27, 2009 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00195351 History of Changes |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Committee of Ethics in Research; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Mexico: National Council of Science and Technology; United States: Institutional Review Board |
|
Complicated intra-abdominal infection Appendicitis with abscess Perforated diverticulitis Purulent peritonitis Complicated cholecystitis |
|
Gallbladder Diseases Communicable Diseases Metronidazole Anti-Infective Agents Antiprotozoal Agents Gastrointestinal Diseases Tigecycline Physiological Effects of Drugs Infection Diverticulitis Anti-Bacterial Agents Antiparasitic Agents Pathologic Processes Acalculous Cholecystitis |
Appendicitis Biliary Tract Diseases Therapeutic Uses Peritoneal Diseases Cross Infection Peritonitis Cholecystitis Ceftriaxone Intestinal Diseases Pharmacologic Actions Cecal Diseases Digestive System Diseases Radiation-Sensitizing Agents Gastroenteritis |
