Brief Title
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
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 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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.
Secondary Outcome
Number of Microbiologically Evaluable 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
467
Start Date
September 2005
Completion Date
February 2008
Primary Completion Date
February 2008
Eligibility Criteria
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
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT00195351
Organization ID
3074A1-400
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