Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
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).