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

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

This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. 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).

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Appendicitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis
• Intervention / Treatment: Drug: tigecycline; Drug: ceftriaxone plus metronidazole

• Study Type: Interventional
• Enrollment (Actual): 473
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Cairns, Australia, QLD 4870
  • Parkville, Australia, Vic 3050
  • Queensland
    • Nambour, Queensland, Australia, 4560
• China
  • Shanghai, China, 200032
• Denmark
  • Odense, Denmark, 5000
• Finland
  • Lahti, Finland, 15850
  • Seinajoki, Finland, 60220
  • Tampere, Finland, 33101
• France
  • Marseille, France, 13 009
  • Nimes, France, 30 029
  • Pierre Benite, France, 69495
  • Saint Denis, France, 93205
• Germany
  • Bochum, Germany, 44791
  • Frankfurt, Germany, 60590
  • Freiburg, Germany, 79106
  • Heidelberg, Germany, 69120
  • Leipzig, Germany, 04129
  • Luebeck, Germany, 23538
  • Muenster, Germany, 48149
  • Tuebingen, Germany, 72056
• Greece
  • Athens, Greece, 11527
  • Athens, Greece, 12462
  • Thessaloniki, Greece, 54623
• Hong Kong
  • New Territories, Hong Kong
  • Pokfulam, Hong Kong
• India
  • Bhopal, India, 462 038
  • Lucknow, India, 226 014
  • Mumbai, India, 400071
  • New Delhi, India, 110060
  • Andhra
    • Hyderabad, Andhra, India, 500 082
• Italy
  • Brescia, Italy, 25123
  • Genova, Italy, 16132
  • Pavia, Italy, 27100
  • Rome, Italy, 00168
  • Udine, Italy, 33100
  • Vicenza, Italy, 36100
• Philippines
  • Manila, Philippines, 1000
  • Quezon City, Philippines, 1100
  • Quezon City, Philippines, 1105
• Portugal
  • Almada, Portugal, 2801-951
  • Coimbra, Portugal, 3000-075
  • Porto, Portugal, 4099-100
  • Porto, Portugal, 4200-319
• Saudi Arabia
  • Riyadh, Saudi Arabia
• South Africa
  • Bellville, South Africa, 7530
  • Kuilsriver, South Africa, 7580
  • Parow, South Africa, 7505
  • Pietermaritzburg, South Africa, 3201
  • Pretoria, South Africa, 001
• Spain
  • Barcelona, Spain, 08003
  • Bilbao, Spain, 48903
  • Madrid, Spain, 28040
  • Madrid, Spain, 28905
  • Murcia, Spain, 30120
• Switzerland
  • Bern, Switzerland, 3010
  • Geneva, Switzerland, 1211
  • Lugano, Switzerland, 6900
  • Zurich, Switzerland, 8091
• Taiwan
  • Changhua, Taiwan, 500
  • Taichung, Taiwan, 404
  • Tainan, Taiwan
  • Taipei, Taiwan, 100
  • Tao-yuan, Taiwan, 333
• Turkey
  • Ankara, Turkey, 06100
  • Istanbul, Turkey, 34718
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
  • Wigan, United Kingdom, WN1 2NN
  • Cheshire
    • Stockport, Cheshire, United Kingdom, SK2 7JE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
• Fever plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

• Cancer
• Medicines that suppress the immune system
• Dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	Drug: tigecycline; every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
Active Comparator: B	Drug: ceftriaxone plus 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit	CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit	ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. 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.	up to 6 weeks
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.	up to 6 weeks
Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure	Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization	up to 6 weeks

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Spain, infomed@wyeth.com; Principal Investigator: Trial Manager, For Australia, China, Hong Kong, medinfo@wyeth.com; Principal Investigator: Trial Manager, For Denmark, Finland, MedInfoNord@wyeth.com; Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com; Principal Investigator: Trial Manager, For Italy, Greece, decresg@wyeth.com; Principal Investigator: Trial Manager, For Switzerland, med@wyeth.com; Principal Investigator: Trial Manager, For Turkey, Erisc@wyeth.com

Publications and helpful links

General Publications

• Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 30, 2005
• First Submitted That Met QC Criteria: September 30, 2005
• First Posted (Estimate): October 3, 2005

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Intra-Abdominal Infections; Abscess
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Inflammation; Peritoneal Diseases; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Suppuration; Gallbladder Diseases; Biliary Tract Diseases; Cecal Diseases; Diverticular Diseases; Infections; Communicable Diseases; Intraabdominal Infections; Abscess; Cholecystitis; Appendicitis; Peritonitis; Abdominal Abscess; Diverticulitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Ceftriaxone; Tigecycline
• Other Study ID Numbers: 3074A1-315

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No