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

Condition(s) targeted: Skin Diseases, Bacterial

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

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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).

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary endpoint will be the clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit.

Secondary outcome:

To compare the microbiologic efficacy of tigecycline with that of the comparator in the microbiologically evaluable(ME)population

To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cSSSI

To compare health care utilization between the treatment groups.

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 in the hospital 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

Trial Manager, Email: clintrialparticipation@wyeth.com

Quebec G1V 4G5, Canada; Recruiting

Hong Kong, Hong Kong; Recruiting

Ramat Gan 52621, Israel; Recruiting

Seoul 120-752, Korea, Republic of; Recruiting

Daejeon 301-721, Korea, Republic of; Recruiting

Seoul 133-791, Korea, Republic of; Recruiting

Incheon 405-760, Korea, Republic of; Recruiting

Beirut 110 32090, Lebanon; Recruiting

Pulau Pinang 10990, Malaysia; Recruiting

Manila 1000, Philippines; Recruiting

Manila 1014, Philippines; Recruiting

Singapore 169608, Singapore; Recruiting

Cape Town 7531, South Africa; Recruiting

Gauteng 0181, South Africa; Recruiting

Mpumalanga 1050, South Africa; Recruiting

KZ-Natal 3610, South Africa; Recruiting

Taipei 220, Taiwan; Recruiting

Bangkok 10700, Thailand; Recruiting

Bangkok 10400, Thailand; Recruiting

Bangkok 10330, Thailand; Recruiting

Scottsdale, Arizona 85251, United States; Recruiting

Jonesboro, Arkansas 72401, United States; Recruiting

Mission Viejo, California 92691, United States; Recruiting

National City, California 91950, United States; Recruiting

Chula Vista, California 91911, United States; Recruiting

Denver, Colorado 80218, United States; Recruiting

Washington, District of Columbia 20017, United States; Recruiting

Washington, District of Columbia 20037, United States; Recruiting

Orlando, Florida 32803, United States; Recruiting

Vero Beach, Florida 32960, United States; Recruiting

Ft. Gordon, Georgia 30905, United States; Recruiting

Idaho Falls, Idaho 83404, United States; Recruiting

Springfield, Illinois 62702, United States; Recruiting

Decatur, Illinois 62526, United States; Recruiting

Naperville, Illinois 60540, United States; Recruiting

Topeka, Kansas 66606, United States; Recruiting

Winnipeg, Manitoba R3A 1R9, Canada; Recruiting

Cambridge, Massachusetts 02139, United States; Recruiting

Worcester, Massachusetts 01655, United States; Recruiting

Detroit, Michigan 48202, United States; Recruiting

Lincoln, Nebraska 68510, United States; Recruiting

Neptune, New Jersey 07754, United States; Recruiting

Hackensack, New Jersey 07601, United States; Recruiting

Elmira, New York 14905, United States; Recruiting

New Hyde Park, New York 11040, United States; Recruiting

Buffalo, New York 14215, United States; Recruiting

Lima, Ohio 45801, United States; Recruiting

Columbus, Ohio 43214, United States; Recruiting

Lansdale, Pennsylvania 19446, United States; Recruiting

Philadelphia, Pennsylvania 19140, United States; Recruiting

Chicoutimi, Quebec G7H 5H6, Canada; Recruiting

Trois-Rivieres, Quebec G8Z 3R9, Canada; Recruiting

Sherbrooke, Quebec J1H 5N4, Canada; Recruiting

Montreal, Quebec H1T 2M4, Canada; Recruiting

Saskatoon, Saskatchewan S7N 0W8, Canada; Recruiting

Fort Worth, Texas 76104, United States; Recruiting

Houston, Texas 77026, United States; Recruiting

Ft. Worth, Texas 76104, United States; Recruiting

Starting date: September 2006
Ending date: October 2008
Last updated: December 19, 2007