Status:
COMPLETED
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Appendicitis
Cholecystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 (Compl...
Eligibility Criteria
Inclusion
- 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
- Cancer
- Medicines that suppress the immune system
- Dialysis
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT00195351
Start Date
September 1 2005
End Date
February 1 2008
Last Update
February 25 2013
Active Locations (66)
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1
Mobile, Alabama, United States, 36617
2
Laguna Hills, California, United States, 92653
3
Los Angeles, California, United States, 90033
4
Orange, California, United States, 92868