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

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Brief Title

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

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

Brief Summary

      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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Appendicitis

Intervention

tigecycline

Study Arms / Comparison Groups

 A
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

473

Start Date

October 2005

Completion Date

September 2008

Primary Completion Date

September 2008

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Monitor, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT00230971

Organization ID

3074A1-315

Responsible Party

Sponsor

Study Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study Sponsor

Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

February 2013