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

February 20, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

467

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
      • Buenos Aires, Argentina, C1118AAT
      • Buenos Aires, Argentina, C1425DUH
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80810-050
    • SP
      • Sao Paulo, SP, Brazil, 01323-010
      • Sao Paulo, SP, Brazil, 04330-020
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 5G4
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
      • Oshawa, Ontario, Canada, L1H 1B9
      • Toronto, Ontario, Canada, M5T 2S8
      • Toronto, Ontario, Canada, M1E 5E9
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H2X 3J4
      • Rimouski, Quebec, Canada, G5L 5T1
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
  • Chile
      • Santiago, Chile
      • Vina del Mar, Chile
  • Mexico
      • Mexico D.F. CP, Mexico, 03100
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
    • California
      • Laguna Hills, California, United States, 92653
      • Los Angeles, California, United States, 90033
      • Orange, California, United States, 92868
      • Palm Springs, California, United States, 92262
      • San Diego, California, United States, 92134
      • Torrance, California, United States, 90509
    • Colorado
      • Denver, Colorado, United States, 80204
      • Denver, Colorado, United States, 80262
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • Delaware
      • Newark, Delaware, United States, 19718
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Indianapolis, Indiana, United States, 46202
      • Indianapolis, Indiana, United States, 46280
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Springfield, Massachusetts, United States, 01199
      • West Roxbury, Massachusetts, United States, 02132
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Grand Rapids, Michigan, United States, 49506
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
    • Missouri
      • St. Louis, Missouri, United States, 63110
      • St. Louis, Missouri, United States, 63131
    • Montana
      • Butte, Montana, United States, 59701
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • New Hampshire
      • Laconia, New Hampshire, United States, 03246
    • New York
      • Buffalo, New York, United States, 14215
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Cleveland, Ohio, United States, 44109
      • Columbus, Ohio, United States, 43215
      • Columbus, Ohio, United States, 43210
      • Toledo, Ohio, United States, 43608
      • Zanesville, Ohio, United States, 43701
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
    • Texas
      • Corsiana, Texas, United States, 75151
      • Fort Worth, Texas, United States, 76135
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77026
    • Utah
      • Salt Lake City, Utah, United States, 84102
    • Virginia
      • Charlottesville, Virginia, United States, 22906
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.
Time Frame: 10-21 days after the last dose of test article
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.
Time Frame: 10-21 days after the last dose of test article
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
Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.
Time Frame: 10-21 days after the last dose of test article
Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.
10-21 days after the last dose of test article

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (ESTIMATE)

September 19, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3074A1-400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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