At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 473 enrolled

Drug / intervention

tigecycline +1 moredrug

Likely dose

Tigecycline 100 mg initial dose followed by 50 mg every 12 hours IV, or ceftriaxone sodium 2 g once daily IV plus metronidazole 1–2 g daily IV in divided dosesAI-extracted

Key inclusion· 2

✓Clinical diagnosis of complicated intra-abdominal infection requiring surgery within 24 hours
✓Fever plus symptoms such as nausea, vomiting, or abdominal pain

Key exclusion· 3

✕Cancer
✕Immunosuppressive medications
✕Dialysis dependence

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00230971

NCT00230971Phase 4Completed

Compare CT.gov

A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Oct 3, 2005·Updated Feb 25, 2013

In Brief

A Phase 4 clinical trial evaluating tigecycline and ceftriaxone plus metronidazole for Appendicitis and 5 related conditions. Completed, enrolled 473 participants across 68 sites in 19 countries.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAppendicitis, Cholecystitis, Diverticulitis, Intra-Abdominal Abscess, Intra-Abdominal Infection, Peritonitis

CountriesAustralia, China, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Collaborators--

Timeline

Phase 4CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2005

First PostedOct 2005

Primary CompletionSep 2008

TodayJul 2026

First PostedOct 3, 2005

Enrollment StartOct 1, 2005

Primary CompletionSep 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.9 yearsPosted 20.7 years ago

Interventions

tigecyclinedrug

every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

ceftriaxone plus metronidazoledrug

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.