NCT00195351

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 467 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Appendicitis
• Cholecystitis
• Cross Infection
• Diverticulitis
• Peritonitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2005-09-19
• Last updated: 2013-02-25
• Results posted: 2009-06-10

Locations

66 sites across 6 countries: United States, Argentina, Brazil, Canada, Chile, Mexico