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NCT00368537
PHASE4

Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2006-09

Completion Date

2008-09

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

DRUG

Tigecycline

Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)

DRUG

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.

Locations (57)

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 Gordon, 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

Sherbrooke, Quebec, Canada

Trois-Rivières, Quebec, Canada

Saskatoon, Saskatchewan, Canada

Québec, 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