Brief Title
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
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
Brief 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).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit
Secondary Outcome
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit
Condition
Appendicitis
Intervention
tigecycline
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
473
Start Date
October 2005
Completion Date
September 2008
Primary Completion Date
September 2008
Eligibility Criteria
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
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00230971
Organization ID
3074A1-315
Responsible Party
Sponsor
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
February 2013