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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00368537 |
Purpose
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. |
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| United States, Arizona | |
| Scottsdale, Arizona, United States, 85251 | |
| United States, Arkansas | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Mission Viejo, California, United States, 92691 | |
| National City, California, United States, 91950 | |
| Chula Vista, California, United States, 91911 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80218 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20017 | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Orlando, Florida, United States, 32803 | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| Ft. Gordon, Georgia, United States, 30905 | |
| United States, Idaho | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Springfield, Illinois, United States, 62702 | |
| Decatur, Illinois, United States, 62526 | |
| Naperville, Illinois, United States, 60540 | |
| United States, Kansas | |
| Topeka, Kansas, United States, 66606 | |
| United States, Massachusetts | |
| Cambridge, Massachusetts, United States, 02139 | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48202 | |
| United States, Nebraska | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, New Jersey | |
| Neptune, New Jersey, United States, 07754 | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Elmira, New York, United States, 14905 | |
| New Hyde Park, New York, United States, 11040 | |
| Buffalo, New York, United States, 14215 | |
| United States, Ohio | |
| Lima, Ohio, United States, 45801 | |
| Columbus, Ohio, United States, 43214 | |
| United States, Pennsylvania | |
| Lansdale, Pennsylvania, United States, 19446 | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Texas | |
| Fort Worth, Texas, United States, 76104 | |
| Houston, Texas, United States, 77026 | |
| Ft. Worth, Texas, United States, 76104 | |
| Canada | |
| Quebec, Canada, G1V 4G5 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Quebec | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Trois-Rivieres, Quebec, Canada, G8Z 3R9 | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Hong Kong | |
| Hong Kong, Hong Kong | |
| Israel | |
| Ramat Gan, Israel, 52621 | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 133-791 | |
| Daejeon, Korea, Republic of, 301-721 | |
| Seoul, Korea, Republic of, 120-752 | |
| Incheon, Korea, Republic of, 405-760 | |
| Lebanon | |
| Beirut, Lebanon, 110 32090 | |
| Malaysia | |
| Pulau Pinang, Malaysia, 10990 | |
| Philippines | |
| Manila, Philippines, 1000 | |
| Manila, Philippines, 1014 | |
| Singapore | |
| Singapore, Singapore, 169608 | |
| South Africa | |
| Cape Town, South Africa, 7531 | |
| Gauteng, South Africa, 0181 | |
| Mpumalanga, South Africa, 1050 | |
| KZ-Natal, South Africa, 3610 | |
| Taiwan | |
| Taipei, Taiwan, 220 | |
| Thailand | |
| Bangkok, Thailand, 10330 | |
| Bangkok, Thailand, 10400 | |
| Bangkok, Thailand, 10700 | |
| 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 |
More Information
| 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 Molecular Mechanisms of Pharmacological Action Skin Diseases Tigecycline Ampicillin Clavulanic Acids Enzyme Inhibitors Sultamicillin |
Infection Amoxicillin-Potassium Clavulanate Combination Pharmacologic Actions Sulbactam Anti-Bacterial Agents Skin Diseases, Infectious Therapeutic Uses Skin Diseases, Bacterial Clavulanic Acid |
