Trials / Completed
CompletedNCT00230971
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 473 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tigecycline | every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours) |
| DRUG | ceftriaxone plus metronidazole | 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. |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2005-10-03
- Last updated
- 2013-02-25
- Results posted
- 2010-04-26
Locations
68 sites across 19 countries: Australia, China, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00230971. Inclusion in this directory is not an endorsement.