Conditions: Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis
Keywords: Intra-Abdominal Infections Abscess
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 473
Healthy volunteers: no

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).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: tigecycline intervention 2: ceftriaxone plus metronidazole
Intervention descriptions: intervention 1: every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours) intervention 2: Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.

Protocol document: