Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00368537 |
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavutanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).
Condition | Intervention | Phase |
---|---|---|
Skin Diseases, Bacterial |
Drug: Tigecycline Drug: ampicillin-sulbactam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections |
Enrollment: | 550 |
Study Start Date: | September 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Arm 1: Tigecycline
|
Drug: Tigecycline
Treatment A: Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
|
2: Active Comparator
Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
|
Drug: ampicillin-sulbactam
Ampiciliin-sulbactam: 1.5 g (1 g amplicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) IV every 6 hrs or Amoxicillin-clavulnate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs. A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintainance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with MRSA is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glucopeptide may be discontinued. |
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 |
Principal Investigator: | Trial Manager | For Hong Kong: medinfo@wyeth.com |
Principal Investigator: | Trial Manager | For South Africa: ZAFinfo@wyeth.com |
Principal Investigator: | Trial Manager | For Taiwan: medinfo@wyeth.com |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3074A1-900 |
Study First Received: | August 21, 2006 |
Last Updated: | July 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00368537 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Institutional Review Board; Brazil: Ministry of Health; China: Ministry of Health; Colombia: Institutional Review Board; France: Ministry of Health; Hong Kong: Department of Health; India: Ministry of Health; Ireland: Ministry of Health; Italy: Ethics Committee; Lebanon: Institutional Review Board; Malaysia: Ministry of Health; Mexico: Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Philippines: Department of Health; Portugal: National Pharmacy and Medicines Institute; Singapore: Health Sciences Authority; South Africa: Medicines Control Council; South Korea: Korea Food and Drug Administration (KFDA); Spain: Ministry of Health; Taiwan: Department of Health; Thailand: Ethical Committee; Turkey: Ministry of Health; United Arab Emirates: General Authority for Health Services for Abu Dhabi; United Kingdom: National Health Service |
skin infection antibiotics |
Bacterial Infections Anti-Infective Agents Amoxicillin Teicoplanin Skin Diseases Tigecycline Clavulanic Acids Ampicillin |
Sultamicillin Amoxicillin-Potassium Clavulanate Combination Sulbactam Anti-Bacterial Agents Skin Diseases, Infectious Skin Diseases, Bacterial Clavulanic Acid Vancomycin |
Bacterial Infections Anti-Infective Agents Amoxicillin Molecular Mechanisms of Pharmacological Action Skin Diseases Tigecycline Ampicillin Enzyme Inhibitors Sultamicillin |
Infection Amoxicillin-Potassium Clavulanate Combination Pharmacologic Actions Sulbactam Anti-Bacterial Agents Skin Diseases, Infectious Therapeutic Uses Skin Diseases, Bacterial Clavulanic Acid |