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

NCT00195351 | Completed Phase 4 Results

• 1 other identifier: 3074A1-400
• Study Type: interventional
• Target: 467
• Locations: 6 countries
• Sites: 66

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

Keywords

Complicated intra-abdominal infection; Appendicitis with abscess; Perforated diverticulitis; Purulent peritonitis; Complicated cholecystitis

Outcome Measures

Primary Outcomes (1)

• Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.

  The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.

  10-21 days after the last dose of test article

Secondary Outcomes (2)

• Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.

  10-21 days after the last dose of test article

• Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.

  10-21 days after the last dose of test article

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: tigecycline

B

ACTIVE COMPARATOR

Drug: ceftriaxone sodium + metronidazole

Interventions

tigecycline DRUG

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

A

ceftriaxone sodium + metronidazole 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.

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cancer
• Medicines that suppress the immune system
• Dialysis

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (66)

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Mobile, Alabama, 36617, United States

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Laguna Hills, California, 92653, United States

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Los Angeles, California, 90033, United States

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Orange, California, 92868, United States

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Palm Springs, California, 92262, United States

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San Diego, California, 92134, United States

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Torrance, California, 90509, United States

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Denver, Colorado, 80204, United States

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Denver, Colorado, 80262, United States

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Hartford, Connecticut, 06102, United States

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Newark, Delaware, 19718, United States

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Washington D.C., District of Columbia, 20037, United States

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Miami, Florida, 33136, United States

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Atlanta, Georgia, 30342, United States

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Honolulu, Hawaii, 96813, United States

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Chicago, Illinois, 60612, United States

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Indianapolis, Indiana, 46202, 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

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Detroit, Michigan, 48201, United States

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Grand Rapids, Michigan, 49506, United States

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Minneapolis, Minnesota, 55422, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63131, United States

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Butte, Montana, 59701, United States

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Lincoln, Nebraska, 68510, United States

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Laconia, New Hampshire, 03246, United States

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Buffalo, New York, 14215, United States

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Bismarck, North Dakota, 58501, United States

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Fargo, North Dakota, 58122, United States

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Cleveland, Ohio, 44109, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43215, United States

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Toledo, Ohio, 43608, United States

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Zanesville, Ohio, 43701, United States

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Pittsburgh, Pennsylvania, 15261, United States

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Corsiana, Texas, 75151, United States

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Fort Worth, Texas, 76135, United States

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Houston, Texas, 77026, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84102, United States

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Charlottesville, Virginia, 22906, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53226, United States

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Buenos Aires, C1118AAT, Argentina

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Buenos Aires, C1425DUH, Argentina

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Buenos Aires, C1431FWO, Argentina

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Curitiba, Paraná, 80810-050, Brazil

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São Paulo, São Paulo, 01323-010, Brazil

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São Paulo, São Paulo, 04330-020, Brazil

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Calgary, Alberta, T2N 2T9, Canada

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Victoria, British Columbia, V8T 5G4, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Oshawa, Ontario, L1H 1B9, Canada

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Toronto, Ontario, M1E 5E9, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Rimouski, Quebec, G5L 5T1, Canada

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Trois-Rivières, Quebec, G8Z 3R9, Canada

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Santiago, Chile

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Viña del Mar, Chile

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Mexico D.F. CP, 03100, Mexico

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Related Publications (1)

• 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.

  PMID: 20670293 DERIVED

MeSH Terms

Conditions

Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis

Interventions

Tigecycline; Ceftriaxone; Metronidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Gallbladder Diseases; Biliary Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diverticular Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 25, 2013
• Results First Posted: June 10, 2009

Record last verified: 2013-02

Locations

BR (3); CA (11); AR (3); ME (1); US (46); CL (2)