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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Diseases, Bacterial

Intervention: Tigecycline (Drug); ampicillin-sulbactam (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager, Principal Investigator, Affiliation: For Hong Kong: medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For South Africa: ZAFinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Taiwan: medinfo@wyeth.com

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit

Secondary outcome:

Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit

Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit

Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate

Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of complicated skin or skin structure infection

- Male or female, 18 years or older

- Need for intravenous treatment for 4 to 14 days

Exclusion Criteria:

- Skin infection that can be treated by surgery & wound care alone

- 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

Locations and Contacts

Quebec G1V 4G5, Canada

Hong Kong, Hong Kong

Ramat Gan 52621, Israel

Daejeon 301-721, Korea, Republic of

Incheon 405-760, Korea, Republic of

Seoul 120-752, Korea, Republic of

Seoul 133-791, Korea, Republic of

Beirut 110 32090, Lebanon

Pulau Pinang 10990, Malaysia

Manila 1000, Philippines

Manila 1014, Philippines

Singapore 169608, Singapore

Cape Town 7531, South Africa

Gauteng 0181, South Africa

KZ-Natal 3610, South Africa

Mpumalanga 1050, South Africa

Taipei 220, Taiwan

Bangkok 10330, Thailand

Bangkok 10400, Thailand

Bangkok 10700, Thailand

Scottsdale, Arizona 85251, United States

Jonesboro, Arkansas 72401, United States

Chula Vista, California 91911, United States

Mission Viejo, California 92691, United States

National City, California 91950, United States

Denver, Colorado 80218, United States

Washington, District of Columbia 20017, United States

Washington, District of Columbia 20037, United States

Orlando, Florida 32803, United States

Vero Beach, Florida 32960, United States

Ft. Gordon, Georgia 30905, United States

Idaho Falls, Idaho 83404, United States

Decatur, Illinois 62526, United States

Naperville, Illinois 60540, United States

Springfield, Illinois 62702, United States

Topeka, Kansas 66606, United States

Winnipeg, Manitoba R3A 1R9, Canada

Cambridge, Massachusetts 02139, United States

Worcester, Massachusetts 01655, United States

Detroit, Michigan 48202, United States

Lincoln, Nebraska 68510, United States

Hackensack, New Jersey 07601, United States

Neptune, New Jersey 07754, United States

Buffalo, New York 14215, United States

Elmira, New York 14905, United States

New Hyde Park, New York 11040, United States

Columbus, Ohio 43214, United States

Lima, Ohio 45801, United States

Lansdale, Pennsylvania 19446, United States

Philadelphia, Pennsylvania 19140, United States

Chicoutimi, Quebec G7H 5H6, Canada

Montreal, Quebec H1T 2M4, Canada

Sherbrooke, Quebec J1H 5N4, Canada

Trois-Rivieres, Quebec G8Z 3R9, Canada

Saskatoon, Saskatchewan S7N 0W8, Canada

Fort Worth, Texas 76104, United States

Ft. Worth, Texas 76104, United States

Houston, Texas 77026, United States

Additional Information

Starting date: September 2006
Last updated: August 8, 2012

Page last updated: August 23, 2015

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