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