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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Cross Infection; Cholecystitis; Appendicitis; Peritonitis; Diverticulitis

Treatments: Drug: tigecycline; Drug: ceftriaxone sodium + metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195351

3074A1-400

Details and patient eligibility

About

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).

Enrollment: 467 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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467 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: tigecycline

B

Active Comparator group

Treatment:

Drug: ceftriaxone sodium + metronidazole