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| Sponsored by: |
Wyeth |
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00230971 |
Purpose
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).
| Condition | Intervention | Phase |
|
Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis |
Drug: tigecycline Drug: ceftriaxone plus metronidazole |
Phase IV |
| MedlinePlus related topics: | Appendicitis Diverticulosis and Diverticulitis |
| ChemIDplus related topics: | Ceftriaxone Ceftriaxone Sodium Tigecycline Metronidazole Metronidazole hydrochloride Metronidazole phosphate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 430 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Active Comparator |
Drug: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
|
| B: Active Comparator |
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.
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations |
Show 68 Study Locations |
| Wyeth |
| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For Australia, China, Hong Kong, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Taiwan, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Denmark, Finland, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, MedinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For South Africa, ZAFinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, Greece, decresg@wyeth.com |
| Principal Investigator: | Trial Manager | For UK, ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Switzerland, med@wyeth.com |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
| Principal Investigator: | Trial Manager | For Turkey, Erisc@wyeth.com |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3074A1-315 |
| First Received: | September 30, 2005 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00230971 |
| Health Authority: | European Union: European Medicines Agency |
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