Clinical Trial: Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open Label Study to Evaluate the Efficacy and Safety of Tigecycline to Treat Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Patients

Brief Summary: In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.

Detailed Summary: To evaluate the efficacy and safety of tigecycline to treat complicated intra-abdominal infections in hospitalized patients. Both the clinical response profile and the microbiological response profile will be assessed. The primary endpoint will be clinical response within the microbiological evaluable population at the test-of-cure assessment.
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.

Original Primary Outcome: Same as current

Current Secondary Outcome: microbiological response (eradicated, persistence, superinfection, or indeterminate) at the patient level, microbiological response (eradicated, persistence, or indeterminate) at the pathogen level (overall and resistant pathogens) clinical

Original Secondary Outcome: Same as current

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: June 18, 2007
Date Started: August 2006
Date Completion:
Last Updated: July 6, 2009
Last Verified: July 2009