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 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 Type: Interventional

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

Study Primary Completion Date: February 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 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.

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

• Clinical Response in the microbiologically evaluable population
  • Time Frame: 10-21 days after the last dose of test article
    Safety Issue?: No
• Microbiological Response at the subject and pathogen levels
  • Time Frame: 10-21 days after the last dose of test article
    Safety Issue?: No
• Overall Response defined as a combination of the Clinical Response and the Microbiological Response at the subject level
  • 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 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

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 December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195351

Study ID Number: 3074A1-400

ClinicalTrials.gov Identifier: NCT00195351

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica