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

Phase 4 Completed 473 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2005-10
Primary completion: 2008-09
Completion: 2008-09

Publications

Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ceftriaxone	Other / unclassified	2 g	Intravenous
Comparator	Metronidazole	Small molecule	1 g	Intravenous
Comparator	Metronidazole	Small molecule	2 g	Intravenous
Comparator	Tigecycline	Small molecule	50 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications