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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Cholecystitis; Appendicitis; Peritonitis; Intra-Abdominal Infection; Intra-Abdominal Abscess; Diverticulitis

Treatments: Drug: tigecycline; Drug: ceftriaxone plus metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00230971

3074A1-315

Details and patient eligibility

About

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).

Enrollment: 473 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
• Fever plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion criteria

• Cancer
• Medicines that suppress the immune system
• Dialysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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473 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: tigecycline

B

Active Comparator group

Treatment:

Drug: ceftriaxone plus metronidazole