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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00195351 |
This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. 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 |
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Appendicitis Cholecystitis Cross Infection Diverticulitis Peritonitis |
Drug: tigecycline Drug: ceftriaxone sodium + 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 |
Estimated Enrollment: | 430 |
Study Start Date: | September 2005 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
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B: Active Comparator |
Drug: ceftriaxone sodium + 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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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3074A1-400 |
Study First Received: | September 12, 2005 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00195351 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Committee of Ethics in Research; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Mexico: National Council of Science and Technology; United States: Institutional Review Board |
Complicated intra-abdominal infection Appendicitis with abscess Perforated diverticulitis Purulent peritonitis Complicated cholecystitis |
Gallbladder Diseases Metronidazole Tigecycline Gastrointestinal Diseases Peritonitis Cholecystitis Ceftriaxone Intestinal Diseases Diverticulitis |
Digestive System Diseases Acalculous Cholecystitis Abscess Appendicitis Biliary Tract Diseases Peritoneal Diseases Gastroenteritis Cross Infection |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Antiparasitic Agents Antiprotozoal Agents Pathologic Processes |
Radiation-Sensitizing Agents Therapeutic Uses Physiological Effects of Drugs Infection Pharmacologic Actions Cecal Diseases |