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”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: tigecycline
  • every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• Clinical response in the clinically evaluable population at the Test-of-Cure visit.
  • Time Frame: 10-21 days after the last dose of test article.
    Safety Issue?: No

Secondary Measures

• To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population
  • Time Frame: 10-21 days after the last dose of test article.
    Safety Issue?: No
• To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI
  • Time Frame: 10-21 days after the last dose of test article.
    Safety Issue?: No
• To compare health care utilization between treatment groups
  • Time Frame: 10-21 days after the last dose of test article.
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00230971

Study ID Number: 3074A1-315

ClinicalTrials.gov Identifier: NCT00230971

Health Authority: European Union: European Medicines Agency