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| Sponsor: | 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 |
| 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 |
| 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 |
|---|---|
| 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.
|
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
Hide Study Locations| Australia | |
| Parkville, Australia, VIC 3050 | |
| Cairns, Australia, QLD 4870 | |
| Australia, Queensland | |
| Nambour, Queensland, Australia, 4560 | |
| China | |
| Shanghai, China, 200032 | |
| Denmark | |
| Odense, Denmark, 5000 | |
| Finland | |
| Lahti, Finland, 15850 | |
| Tampere, Finland, 33101 | |
| Seinajoki, Finland, 60220 | |
| France | |
| Nimes, France, 30 029 | |
| Marseille, France, 13 009 | |
| Saint Denis, France, 93205 | |
| Pierre Benite, France, 69495 | |
| Germany | |
| Tuebingen, Germany, 72056 | |
| Freiburg, Germany, 79106 | |
| Leipzig, Germany, 04129 | |
| Heidelberg, Germany, 69120 | |
| Frankfurt, Germany, 60590 | |
| Bochum, Germany, 44791 | |
| Luebeck, Germany, 23538 | |
| Muenster, Germany, 48149 | |
| Greece | |
| Thessaloniki, Greece, 54623 | |
| Athens, Greece, 11527 | |
| Athens, Greece, 12462 | |
| Hong Kong | |
| New Territories, Hong Kong | |
| Pokfulam, Hong Kong | |
| India | |
| Lucknow, India, 226 014 | |
| Bhopal, India, 462 038 | |
| Mumbai, India, 400071 | |
| New Delhi, India, 110060 | |
| India, Andhra | |
| Hyderabad, Andhra, India, 500 082 | |
| Italy | |
| Genova, Italy, 16132 | |
| Udine, Italy, 33100 | |
| Brescia, Italy, 25123 | |
| Rome, Italy, 00168 | |
| Vicenza, Italy, 36100 | |
| Pavia, Italy, 27100 | |
| Philippines | |
| Quezon City, Philippines, 1100 | |
| Manila, Philippines, 1000 | |
| Quezon City, Philippines, 1105 | |
| Portugal | |
| Almada, Portugal, 2801-951 | |
| Porto, Portugal, 4200-319 | |
| Coimbra, Portugal, 3000-075 | |
| Porto, Portugal, 4099-100 | |
| Saudi Arabia | |
| Riyadh, Saudi Arabia | |
| South Africa | |
| Parow, South Africa, 7505 | |
| Pietermaritzburg, South Africa, 3201 | |
| Kuilsriver, South Africa, 7580 | |
| Pretoria, South Africa, 001 | |
| Bellville, South Africa, 7530 | |
| Spain | |
| Barcelona, Spain, 08003 | |
| Madrid, Spain, 28040 | |
| Madrid, Spain, 28905 | |
| Murcia, Spain, 30120 | |
| Bilbao, Spain, 48903 | |
| Switzerland | |
| Zurich, Switzerland, 8091 | |
| Geneva, Switzerland, 1211 | |
| Bern, Switzerland, 3010 | |
| Lugano, Switzerland, 6900 | |
| Taiwan | |
| Taipei, Taiwan, 100 | |
| Tao-yuan, Taiwan, 333 | |
| Tainan, Taiwan | |
| Taichung, Taiwan, 404 | |
| Changhua, Taiwan, 500 | |
| Turkey | |
| Ankara, Turkey, 06100 | |
| Istanbul, Turkey, 34718 | |
| United Kingdom | |
| Wigan, United Kingdom, WN1 2NN | |
| Birmingham, United Kingdom, B9 5SS | |
| United Kingdom, Cheshire | |
| Stockport, Cheshire, United Kingdom, SK2 7JE | |
| 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 |
| Study First Received: | September 30, 2005 |
| Last Updated: | July 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00230971 History of Changes |
| Health Authority: | European Union: European Medicines Agency |
|
Intra-Abdominal Infections Abscess |
|
Gallbladder Diseases Communicable Diseases Metronidazole Anti-Infective Agents Antiprotozoal Agents Gastrointestinal Diseases Tigecycline Physiological Effects of Drugs Infection Diverticulitis Anti-Bacterial Agents Antiparasitic Agents Pathologic Processes Acalculous Cholecystitis Therapeutic Uses |
Appendicitis Biliary Tract Diseases Peritoneal Diseases Suppuration Abdominal Abscess Peritonitis Cholecystitis Ceftriaxone Intestinal Diseases Pharmacologic Actions Inflammation Cecal Diseases Digestive System Diseases Radiation-Sensitizing Agents Abscess |
