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

NCT ID: NCT00195351

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-02-29

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).

Conditions

Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

tigecycline

Intervention Type: DRUG

every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

B

Group Type: ACTIVE_COMPARATOR

ceftriaxone sodium + metronidazole

Intervention Type: DRUG

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.

Interventions

tigecycline

every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Los Angeles, California, United States

Orange, California, United States

Palm Springs, California, United States

San Diego, California, United States

Torrance, California, United States

Denver, Colorado, United States

Denver, Colorado, United States

Hartford, Connecticut, United States

Mobile, Alabama, United States

Laguna Hills, California, United States

Newark, Delaware, United States

Washington D.C., District of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

West Roxbury, Massachusetts, United States

Detroit, Michigan, United States

Grand Rapids, Michigan, United States

Minneapolis, Minnesota, United States

St Louis, Missouri, United States

St Louis, Missouri, United States

Butte, Montana, United States

Lincoln, Nebraska, United States

Laconia, New Hampshire, United States

Buffalo, New York, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Columbus, Ohio, United States

Toledo, Ohio, United States

Zanesville, Ohio, United States

Pittsburgh, Pennsylvania, United States

Corsiana, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Madison, Wisconsin, United States

Milwaukee, Wisconsin, United States

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Curitiba, Paraná, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Calgary, Alberta, Canada

Victoria, British Columbia, Canada

Ajax, Ontario, Canada

Oshawa, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Chicoutimi, Quebec, Canada

Greenfield Park, Quebec, Canada

Montreal, Quebec, Canada

Rimouski, Quebec, Canada

Trois-Rivières, Quebec, Canada

Santiago, , Chile

Viña del Mar, , Chile

Mexico D.F. CP, , Mexico

Countries

United States; Argentina; Brazil; Canada; Chile; Mexico

References

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.

Reference Type: DERIVED

PMID: 20670293 (View on PubMed)

Other Identifiers

3074A1-400

Identifier Type: -

Identifier Source: org_study_id