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| Sponsor: | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Information provided by: | Wyeth is now a wholly owned subsidiary of Pfizer |
| 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 473 |
| Study Start Date: | October 2005 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
|
| Active Comparator: B |
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.
|
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| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| 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 (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00230971 History of Changes |
| Other Study ID Numbers: | 3074A1-315 |
| Study First Received: | September 30, 2005 |
| Results First Received: | September 30, 2009 |
| Last Updated: | April 5, 2010 |
| Health Authority: | European Union: European Medicines Agency; Australia: Human Research Ethics Committee; Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee; India: Institutional Review Board; Republic of the Philippines: Ethics Committee; Taiwan: Institutional Review Board; Denmark: Ethics Committee; Finland: National Advisory Board on Health Care Ethics; France: Institutional Ethical Committee; Germany: Ethics Commission; Greece: Ethics Committee; Italy: Ethics Committee; Saudi Arabia: Ethics Committee; South Africa: Human Research Ethics Committee; Spain: Ethics Committee; Switzerland: Ethikkommission; Turkey: Ministry of Health; United Kingdom: Research Ethics Committee |
|
Intra-Abdominal Infections Abscess |
|
Abscess Appendicitis Cholecystitis Acalculous Cholecystitis Diverticulitis Peritonitis Abdominal Abscess Suppuration Infection Inflammation Pathologic Processes Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Cecal Diseases |
Intestinal Diseases Gallbladder Diseases Biliary Tract Diseases Peritoneal Diseases Ceftriaxone Tigecycline Metronidazole Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents |