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

Completed · Phase 4

Conditions studied: Appendicitis, Cholecystitis, Cross Infection, Diverticulitis, Peritonitis

In brief

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).

Key facts

Study ID

NCT00195351

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

467

Starts

2005-09-01

Expected to finish

2008-02-01

Last updated by the study team

2013-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Cancer
• Medicines that suppress the immune system
• Dialysis

Where it is running

• Study site — Laguna Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Palm Springs, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — West Roxbury, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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