Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
NCT ID: NCT00368537
Last Updated: 2012-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
550 participants
INTERVENTIONAL
2006-09-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Arm 1: Tigecycline
Tigecycline
Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
2
Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
ampicillin-sulbactam
Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 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 maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.
Interventions
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Tigecycline
Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
ampicillin-sulbactam
Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 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 maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.
Eligibility Criteria
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Inclusion Criteria
* Male or female, 18 years or older
* Need for intravenous treatment for 4 to 14 days
Exclusion Criteria
* Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
* Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Scottsdale, Arizona, United States
Jonesboro, Arkansas, United States
Chula Vista, California, United States
Mission Viejo, California, United States
National City, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Vero Beach, Florida, United States
Fort Eisenhower, Georgia, United States
Idaho Falls, Idaho, United States
Decatur, Illinois, United States
Naperville, Illinois, United States
Springfield, Illinois, United States
Topeka, Kansas, United States
Cambridge, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Lincoln, Nebraska, United States
Hackensack, New Jersey, United States
Neptune City, New Jersey, United States
Buffalo, New York, United States
Elmira, New York, United States
New Hyde Park, New York, United States
Columbus, Ohio, United States
Lima, Ohio, United States
Lansdale, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Winnipeg, Manitoba, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Hong Kong, , Hong Kong
Ramat Gan, , Israel
Beirut, , Lebanon
Pulau Pinang, , Malaysia
Manila, , Philippines
Manila, , Philippines
Singapore, , Singapore
Cape Town, , South Africa
Gauteng, , South Africa
KZ-Natal, , South Africa
Mpumalanga, , South Africa
Daejeon, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Countries
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References
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Matthews P, Alpert M, Rahav G, Rill D, Zito E, Gardiner D, Pedersen R, Babinchak T, McGovern PC; Tigecycline 900 cSSSI Study Group. A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections. BMC Infect Dis. 2012 Nov 12;12:297. doi: 10.1186/1471-2334-12-297.
Other Identifiers
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3074A1-900
Identifier Type: -
Identifier Source: org_study_id